INDEX
Pog.
Product specification sheet 1
Product pictures 2
FDA Certificate 3
Product SDS 4
Product commercial information R
Trademark registration B
‘Company general information and references 4
copy Net
‘Mma Revered
|Alimsteral ppeeragon hs presentation (conten is rotate by copygnt under US. Copyright lus ani the propery Esaipe
mossy, create derivative works, transmit, orn any way exploit and modify any such content or doe such content to canatuct any kind of
‘Biase Copying oon ay contort except proved sbvels egress potted without rir unten permision tyeEzywipe of America
66725 NW 36th ST. Suite 600
‘Miami, FL33166
“+1866 3998867
FACE MASK PRODUCT SPECIFICATION SHEET
Supple [Ezywine of America
[Contact Person: [tex Munoz
Packing Topes/baw, 5 bassibox, 40 boxes/earton
[Carton size [steasea7em
Mask material
iter hyerwhite mekbown fe Natural color
Bor rope Nyion = Spandex [White
Bridae of nose irom + other [Natural color
nner ayer: SS non-woves
fabric tse 258 wine
[Low Fhikd Resbiance: [sonny
pre = 9590.1 micron
pection Standard: TCTCA 7-2019
[Formakichyde content / Gna
pH vahie
ethylene exile restdue/ (w/e)
[Ractorial fikration efficioney (BEE)
[Particulate matter fitration effieloney (PFE
[Breaking strength of the mask bet and the
wan: Not allowed to be detected
Microbial index: .
Iunial colonies! = 100 (CRUE)
[Total bacterial colonies: =200 (CFU/R)Ezycare
PRODUCT PICTURES
PRODUCT PICTURES.
FRONT FRONT WITH ELASTICS Back
Box UPC
Mn
‘CASE PICTURE
MAIN LABEL,
BE A
CASE UPC.
IM
Il,
= ANUUOUILEHFiscal Year 2020
CERTIFICATE OF FDA REGISTRATION
“This certifies that:
‘Quanzhou ezywipe merchandise company limited
Rm1007, 6th block, baidehuifeng, shilong road, Shishi, Fujian, 362700, CHINA
has completed the FDA Estabishment Registration and Device Listing with the US Food & Drug
‘Administration, through UCL-REG SERVICE INC,
Owner/Operator Number: 10053070
Registration Number: 3013433238
Using No. Produet Code: Device Name:
ouz774s FRL FIBER, MEDICALABSORGENT
ours HHO Pad, menstrual unscented
ou778 £70 GARMENT, PROTECTIVE, FOR INCONTINENCE
0373508 Ke ‘BEDDING, DISPOSABLE, MEDICAL
373510 st Respirator, surgical
UCL-REG SERVICE INC. will confirm that such registration remains effective upon request and
presentation of this certificate unl the end of the calendar year stated above, unless said registration is
terminated aftr issuance of this certificate. UCL-REG SERVICE INC. makes no other representations or
warranties, nor does this ceruftcate make any representaiions oF warrantles ro any person or entity other
‘han the named certificate holder, for whose sote benefit itis issued. This certificate does not denote
endorsement or approval ofthe certficate-holder ¥ device ar establishment by the U.S. Food and Drug
Administration. UCL-REG SERVICE INC. assianes no liability to any person or entity in connection with
the foregoing.
Pursuant to 21 CFR 807.39. “ Registration ofa device establishment or assignment ofa registration
‘number does not in any way denote approval of the establishment or its products. Any representation that
creates an impression of official approval because of registration or possession of a registration number
is misleading and constitutes misbranding.”
‘The U.S.Food and Drug Administration does not issue a certificate of registration, nor does the U.S Food
‘and Drieg Administration recognize «certificate of registration, UCL-REG SERVICE INC. is not affiliated
1 - ‘with the US. Food and Drug Administration.
Jc
UCL-REGSERVICE INC,
(Cert, No.: M20033
{602 ROCKWOOD ROAD, WILMINGTON, LA ULGEAG CON
NEW CASTLE DE 19802 USA Expiration Date: 31 December 2020Ezycare
SAFETY DATA SHEET
SECTION I - PRODUCTION IDENTIFICATION
EZYCARE® HEALTH PRODUCTS
MANUFACTURER:
QUANZHOU EZYWIPE MERCHANDISE CO., LTD
UNIT2212-2213, 13TH SOHO, DONGHAI TAHOE, FENGZE
DISTRICT, QUANZHOU, FJ. PRC
+86 (159) 800 70 003
SUPPLIER:
EZYWIPE OF AMERICA
6725 NW 36" St, STE 600
MIAMI, FL 33166
+1 (866) 399-8867
Date: 02/26/2020
Prepared by: Ezycare quality department
‘SECTION Il - MATERIALS
The above products are considered “articles” according to OSHA Hazard Communication Standard 29 CFR
1910.1200 and, as such, are exempt from Safety Data Sheet provisions of 29 CFR
1910.1200(G)(6). As aservicetothe customer, Ezycare haspreparedthis Safety Data Sheettoprovide
appropriate safety and handling information. These products are considered non- hazardous when
used according to accepted practices for the intended use.
COMMON NAME: — USE:
Face Mask Respiratory protection, contamination prevention
Part Data Color
Filter layer-white melt blown 175mmi25g Natural color
Ear rope Nylon + Spandex White
Bridge of nose tron + other Natural color
Outer layer: SS non-woven fabric, 175mmi25g White/Blue
Inner layer: SS non-woven fabric 195mmi25g White
RevdEzycaré
SAFETY DATA SHEET
ASTM LEVEL 1
Filtration Efficiency:
Breathabilty-Delta P:
Flame Spread:
80mmHg
BFE299%
PFE295%@0.1 micron
<4.0 mm H2O/em2
Not applicable
Inspection Standard: TICTCA 7-2019
Test items
Formaldehyde content / (mg/kg)
pH value
Ethylene oxide residue/ (ug/g)
Bacterial filtration efficiency (BFEV%
Particulate matter filtration efficiency (PFE/%)
Ventilation resistance /Pa
Breaking strength of the mask belt and the
joint between the mask belt and the mask
body
Microbial index:
Field of view under the mask
Testing requirements
<20
40-75
10
295
280
<80
210
Pathogenic pyogenic bacteria: Not allowed to be
detected
Total fungal colonies: $100 (CFU/g)
Total bacterial colonies: <200 (CFU/g)
260"
‘SECTION Ill - HAZARD IDENTIFICATION
Emergency Overview
Nounusualconditionsare expected from thisproduct,
PRIMARY ROUTES OF ENTRY:
Inhalation: Not applicable.
Ski
Revd
Shortcontactwith human skinisnotlikelyto produce skinirritation.Ezycare
SAFETY DATA SHEET SDS
Eyes: High concentrations of dust may cause a physical irritation to the eye.
Ingestion: Although not likely to occur in industrial applications, accidental ingestion may
cause irritation of the mouth and gastrointestinal tract.
CHRONIC HEALTH EFFECTS:
There are no known chronic health effects associated with long term use or contact,
with this product.
CARCINOGENICITY:
This product is not known as a carcinogen
MEDICAL CONDITIONS GENERALLY AGGRAVATED BY EXPOSURE:
Respiratory or skin conditions that are aggravated by mechanical ritants may be at an increased risk
for worsening from exposure to this product.
‘SECTION IV - FIRST AID
INHALATION: Not applicable
SKIN: Wash any material off skin with mild soap and cool water. Donotrub or
scratch irritated areas. This may force fibers into the skin, Seek medical
attention if irritation persists.
EVES: Flushwith waterforatleast 15 minutes. Seekmedical attention firritation
persists.
INGESTION: Not expected to occur. Should ingestion take place, the person should be
watched forseveraldays to ensure intestinalblockagedoesnotoccur.
‘SECTION V - FIRE AND EXPLOSION HAZARD DATA
FLASH POINT (METHOD USED) NA
FLAMMABLE LIMIT: LEL:NA —-UEL: NIA
AUTO IGNITION TEMPERATURE: NA
UNUSUAL FIREAND EXPLOSIVE HAZARDS: None
EXTINGUISHING MEDIA: Water, COz, dry chemical or foam,
‘SPECIAL FIRE FIGHTING PROCEDURES: Ina sustained fire, proper protection against
products of combustion must be worn. Use self-
‘contained breathing apparatus (SCBA) and full bunker
turnout gear in a sustained fire.
HAZARDOUS COMBUSTIONPRODUCTS, Ina sustained fir, the yarn will decompose,
releasing minor quantities of decomposition, product
believed to be insufficient to be harmful,Ezycare
SAFETY DATA SHEET
SECTION VI- SPILL OR LEAK PROCEDURES:
STEPS TO BE TAKEN IN CASE MATERIAL IS RELEASED OR SPILLED:
LandSpill: Materialisasolid. Pickup thelarger pieces andwetsweeporvacuumupany
scrapes. Placeinasuitable container for disposal as anon-hazardous waste.
Water Spill: Thismaterialwillsinkand disperse along he bottom of waterwaysand ponds.
Large pieces shouldberemovedandlacedinasuitablecontainerfor disposal.
‘Smaller pieces cannot be easily removed afteritis waterborne; however, the
material is non-hazardous in water.
AiRelease: The material will settle out of the air where itcanbe cleanedas aland spill
SECTION VII - HANDLING AND STORAGE
PRECAUTIONS TO BE TAKEN IN HANDLING: Formaximum comfort, avoid excessive contact
with skin and use good personal hygiene. Avoid
dustformation. Exposure to dust and
decomposition products should be avoided by
ventilation and/or vacuum cleaning,
OTHERPRECAUTIONS: This materialis not an electrical conductor and
may accumulate static charge.
STORAGE TEMPERATURE: NA
STORAGE PRESSURE: NIA
‘SECTION Vill - EXPOSURE CONTROL’ PERSONAL PROTECTION
EXPOSURE LIMITS:
(COMMON NAME: LD-50 ACGIH TLV OSHA PEL
Face Mask Not required Not required Not required
LD-50 = Lethal Dose, 50%
ACGIH = American Conference of Governmental Industrial Hygienists
TLV = Threshold Limit Value
OSHA = Occupational Safety and Health Administration.
PEL = Permissible Exposure LimitsEzycare
SAFETY DATA SHEET SDS
VENTILATION:
Use local exhaust or general room dllution to maintain employee exposures below occupational
exposure limits. Recirculated air should be filtered to remove respirable dust.
RESPIRATORY PROTECTION:
Ifthe use or manufacturing ofthis product generates dust concentrations above the exposure limit,
appropriate certified respirators must be used.
PROTECTIVEGLOVES: Industrial work glovessuggested.
EYE PROTECTION: As generally good practice, safety glasses with side shields should be worn.
OTHER PROTECTIVE CLOTHING OR EQUIPMENT:
None required. Good personal hygiene, barrier creams, caps, coveralls, loose fitting long sleeve shirt
thatcovers tothe base ofthe neckand long pants will maximize comfort. Skinirtitation is known to
‘occur chiefly at pressure points suchas around the neck, wrist, waist, and between fingers.
WORKHYGIENIC PRACTICES: Handleusing goodindustrialhygieneandsafety practices. Wash
thoroughly with mild soap and coolwater afterhandling ofthe material. Keep the workareaclean
ofdustsand fibersreleased duringprocessingor fabrication. Use vacuumequipmenttocleanup
product. Avoid dry sweeping or using compressed air as these techniques re-suspend dusts and
fibers into the air. Have access to a shower and eye wash station.
‘SECTION IX - PHYSICAL DATA
BOILINGPOINT: Not Applicable
MELTING POINT: 160 degree Celsius
FREEZING POINT: Not Applicable
SPECIFIC GRAVITY RANGE (H20=1): NotApplicable
pH NotApplicable
VISCOSITY: NotApplicable
SOLUBILITY INWATER: Insoluble
PERCENT VOLATILE BY VOLUME: None
VAPOR DENSITY (Air=1): Not Applicable
VAPOR PRESSURE mm Hg}: Not Applicable
EVAPORATIONRATE (ButylAcetate=1): NotApplicable
PHYSICAL STATE: solid, odorless,Ezycare
SAFETY DATA SHEET SD:
‘APPEARANCE AND ODOR: Non Woven fabricthatcan bedyeda wide
rangeof colors; odorless.
‘SECTION X - REACTIVITY DATA
STABILITY: Stable
CONDITIONSTOAVOID: None known
INCOMPATIBILITY: Do not store with strong oxidizers
HAZARDOUS POLYMERIZATION: ‘Will notoccur
HAZARDOUS DECOMPOSITION OR BYPRODUCTS:
Hazardous thermal decomposition products include Carbon Monoxide and Carbon Dioxide.
‘SECTION XI - TOXICOLOGICAL INFORMATION
ACUTE EXPOSURE: _No known effect
CHRONIC EXPOSURE: No known effect
IRRITATION:
SENSITIZATION:
CARCINOGENICITY: None of the components present in this material at concentrations equal
toorgreaterthan0.1% is listed by ARC or ACGIHasa carcinogen.
MUTAGENICITY: Not available
EMBRYOTOXICITY: Not available
TERATOGENICITY: Not available
‘SECTION Xil - ECOLOGICAL INFORMATION
This producthas no known eco-toxicological effects.
‘SECTION Xill - DISPOSAL CONSIDERATIONS
WASTE DISPOSAL METHOD: Can beland filled orincineratedin compliance with federal, state,
provincial and local environmental control regulations. Dispose of as any other innocuous material
Productis not a hazardous waste.
‘SECTION XIV - TRANSPORTATION INFORMATION,
DOT SHIPPING NAMES: Not regulatedEzycare
SAFETY DATA SHEET SDS
HAZARD CLASS OR DIVISION: None
SECONDARY: None
IDENTIFICATION NUMBER: None
PACKING GROUP: None
LABEL(S)REQUIRED (ifnot excepted): None
‘SPECIAL PROVISIONS: None
PACKAGE EXCEPTIONS: None
NON-BULK PACKAGING: None
BULK PACKAGING: None
EPA HAZARDOUS SUBSTANCES: None
REPORTABLE QUANIILY: Not Applicable
QUANTITY LIMITATIONS:
PASSENGER AIRCRAFT: None
CARGO AIRCRAFT: None
MARINE POLLUTANTS: None
FREIGHT DESCRIPTION: None
HAZARDOUSMATERIALSHIPPINGDESCRIPTION: None
‘TRANSPORTATION OF DANGEROUS GOODS ~ CANADA,
DOT SHIPPING NAMES: Not regulated
‘TDG HAZARD CLASSIFICATION
PRIMARY: None
‘SECONDARY: None
IMO CLASSIFICATION: None
ICAO/IATACLASSIFICATION: None
PRODUCT IDENTIFICATION NUMBER: None
PACKING GROUP: None
CONTROL TEMPERATURE: None
EMERGENCY TEMPERATURE: None
SCHEDULE XII QUANTITY RESTRICTIONS: None
REPORTABLE QUANTITY FOR US SHIPMENTS: None
IATA PACKAGING INSTRUCTIONS,
PASSENGER/CARGO: None
CARGO ONLY: None
LIMITED QUANTITY: None
MAXIMUM NET QUANTITY PER PACKAGE
PASSENGER/CARGO: None
CARGO ONLY: None
LIMITED QUANTITY: None
SPECIAL PROVISIONS: None
RevdEzycaré
SAFETY DATA SHEET
SECTION XV - REGULATORY INFORMATION
Face masks are consideredarticles, therefore areexemptfromthe following
requirements:
USA’ TSCA - Toxic Substances Control Act
EUROPE: —_ EINECS—European Inventory of Existing Commercial Chemical Substances
CANADA: DSL ~Domestic Substance List
AUSTRALIA: AICS—Australian|nventory of Chemical Substances
KOREA: ECL (KEC!) ~ Korean Existing Chemical Inventory
JAPAN: MITI(ENCS)— Existing and New Chemical Substances
PHILIPPINES: PICCS - Philippines Inventory of Chemicals and Chemical Substances
SARA TITLE Ill Reportable Ingredients: None
‘SECTION XVI - OTHER INFORMATION
The information hereinis given in good faith, butnowarranty, expressedorimpliedis made and we
assume no liability from its use. Users should make their own investigations to determine the
suitability of the information for their particular purposes.
Ezycare® is a registered trademark of Ezywipe of America
RevdEzycare
PRODUCT COMMERCIAL INFORMATION
[UNITS PER BOX
BOXES PER CASE
Jcase size cm
Jcasc size ivciics
Jcross weIGHT KG
|sross WEIGHT LB
Jcem/case
[CASES PER 40'HO.
[GENERAL DESCRIPTION
PRODUCT NAME Respiratory face mask
[sku EZC-FML
Joricin, CHINA
BRAND: EZYCARE
DESCRIPTION Earloop Disposable respiratory mask
LAYER 3
Level: ‘ASTM LEVEL 1
Icouor White/Blue
[OEM AVAILABLE: YES.
PACKING
50
40
L w
51 a
20 16
75
165
0.096
630
46
18qgunited States of Amery,
United States Patent and Trademark Office tg
6
Ezycare
Reg, No, 5,487,237 INNOVATIVE TECHNOL OGIC SOLUTIONS, LLC (DELAWARE LIMITED LIABILITY
Registered Jun. 05, 2018 Me Gress sie 4
Dover, DELAWARE 19901
Int. CL: 5, 10
CLASS 5: Adut diapers Baby diapers; Sanitizing wipes
Trademark FIRST USE 1-15-2017: IN COMMERCE 1-15-2017
Principal Register CLASS 10; Incominence bed pas: ncomtinence sheets; Mail ble het for examining
tables and operating bls Stele sheet surgi!
FIRST USE 1-15-2017: IN COMMERCE 1-15-2017
The colors) ed, bls, and white iste claimed as feat of the mak
sar" appcaring in stylizod form where "E" and *Y
in blue. On top ofthe "2 a blue and white drop
The mark conse ofthe wording
appear in red an "Zand are” app
spears
‘SER, NO, #7140223, FILED 08-16-2016,
Prbet harm
Director of the United States
Patent and Trademark Office