!

(PPE/PFN-B-MR/002)
Technical File: PPE/PFN-B-MR/002 Effective Date: 29 Jul. 2011
Section: Table of Contents Page 1 of 1

TABLE OF CONTENTS

Section Description Revision

i Cover Page -

ii Content Page -

1.0 Product Description, Uses and Specification 002

2.0 Basic Health and Safety Requirements 002

3.0 Manufacturing Process 000

4.0 Quality Control System 000

5.0 Control and Test Facilities 000

6.0 Product Testing 000

7.0 List of pictograms to be used on packages 001

8.0 List of applicable standards 001

9.0 EC Declaration of Conformity 000

 Revision No: 002
Technical File: PPE/PFN-B-MR/002a Effective Date: 9 Apr 2012
Section 1.0: Product Description, Uses and Page 1 of 1
Specification

SECTION 1.0 PRODUCT DESCRIPTION, USES AND DESCRIPTION

1.1 General Description
1.1.1 Glove Type
Glove Family : Powder-free Blue Nitrile Gloves (PFN-B).
Variants : Applicable for smooth or textured or finger-textured surface
and meet the product specification.
Grade : AQL 4.0
1.1.2 Feature
Ambidextrous, Disposable, Beaded Cuff
1.1.3 Material
Made from Synthetic Nitrile Rubber
1.1.4 Colour
Blue colored
1.1.5 Shelf-Life
3 years from date of manufacture.
1.2 Intended Use
This disposable Personal Protective Equipment (PPE) rubber glove is intended to be
worn by an individual for protection against one or more health and safety hazards.
1.3 Classification
Category I : For minimal risk use only.
1.4 Applicable Harmonised Standards
1.4.1 Meet EN 374 – part 1 and 2.
Protective Gloves against water
1.5 Product Specification
Reference
No. Test On Glove Size / Level Specification Test method
1 Dimension Palm Extra-Small 75 ± 5mm
Width Small 85 ± 5mm EN 455
Medium 95 ± 5mm Part 2 and
Large 106 ± 5mm EN 420
Extra-Large 116 ± 5mm
(for special purposes)
Length (Special Request) min. 230mm
2 Water Leakage Test Inspection Level S4 / AQL 4.0 EN 374-2
Performance Level Level 1
3 pH of glove pH 3.5 to pH 9.5 EN 420 &
EN ISO 3071

Confidential
 Revision No: 002
Technical File: PPE/PFN-B-MR/002 Effective Date: 29 Jul. 2011
Section 2.0: Basic Health and Safety Page 1 of 2
Requirements

SECTION 2.0 BASIC HEALTH AND SAFETY REQUIREMENTS

(Annex II)

2.1 General Requirements applicable to Powder-free Nitrile Glove PPE

1.1) The Gloves provide protection against :

i) mechanical action whose effects are superficial (gardening glove).
ii) cleaning materials of weak action and easily reversible effect (gloves
affording protection against dilute detergent solution).
iii) risk encountered in the handling of hot components which do not expose
the user to a temperature exceeding 50 °C or to dangerous impact.
iv) atmospheric agents of a neither exceptional nor extreme nature.
v) minor impact and vibration which do not effect the hands and whose
effects cannot cause irreversible lesions.

1.2) Design of Gloves :

a) Fit both hand, the gloved hands can perform the low risk-related activity
whilst enjoying appropriate protection.
b) The gloves materials and its decomposition products do not adversely affect
user hygiene or health.
c) The contact surface of the glove with the hand is free of roughness, sharp
edges, projection and the likes which may cause excessive irritation or
injuries.
d) These gloves have good finger dexterity and do not impede the user
movement or sensory perception.

1.3) Comfort and efficiency

a) 5 different sizes (Extra-Small, Small, Medium, Large and Extra-large) of
the Gloves are supplied to ensure good fit on user’s hands morphology.
b) The gloves are light, yet strong under foreseeable condition of use. It offers
better puncture resistance than similar natural rubber latex glove.
c) The pH of the gloves are close to neutral and do not cause irritation.
d) These gloves are recommended for users that are allergic to natural rubber.

1.4) Information on the PPE device.

a) “Manufactured for” and address

b i) Storage condition -1) Keep away from moisture.

Of box. 2) Keep away from heat (sun or fluorescence light).
3) Store at 10 – 40 °C
ii) Disposable.

c) The Gloves meet EN 374 – part 1 and 2

d) There is no accessory associated with this PPE.

Confidential
 Revision No: 002
Technical File: PPE/PFN-B-MR/002 Effective Date: 29 Jul. 2011
Section 2.0: Basic Health and Safety Page 2 of 2
Requirements

e) Category I : Use for minimal risks condition (Laboratory, gardening,

general cleaning at temperature of 10 – 50 °C).

f) The obsolescence deadline is 3 years from date of manufacture.

g) For transportation, the gloves are packed in Paper Dispenser Boxes / Plastic
bag. A paper carton then encloses these Dispenser packages.

h) The “Low Chemical Risk and Waterproof” pictograms are placed on the
Dispenser Packages (refer section 7) to signify that the gloves were not
tested against chemicals.

i) The gloves comply with “Council Directive of 21 December 1989 relating

to Personal Protective Equipment, 89/686/EEC.

j) A Notified Body is not required to assess and verify the minimal risks PPE.

2.2 Additional Requirements for PPE Glove.

2.2.1 A bead is provided on the glove cuff to aid in donning of the hand.
2.2.2 The date of obsolescence, 3 years after manufacture is affixed on the
dispenser boxes as the glove deteriorate slightly on aging. The useful life of
the gloves can be prolong with careful storage (refer clause1.4 above).
2.2.3 The glove can be torn by a sufficiently large force, thereby preventing it being
caught-up by a moving object.
2.2.4 The gloves are ambidextrous in design, so it is easily don on the left or right
hands. This also minimizes the time to don the gloves.
2.2.5 The Pictograms “Low Chemical Risk and Water proof” is placed on the
dispenser packages to indicate the risk that the user is protected against.

2.3 Additional Requirements Specific To Particular Risks.

2.3.1 Protection against infective agents.
a) The glove when worn is capable of protecting the user hands against
infective agent (micro-organism) as encountered in general use.
b) The Leak-tightness of the glove does not change on prolong usage, except
when it is cut, puncture or torn. The gloves should then be immediately
changed.

Confidential
 Revision No: 000
Technical File: PPE/PFN-B-MR/002 Effective Date: 10 Dec. 2010
Section 3.0: Manufacturing Process Page 1 of 1

SECTION 3.0 MANUFACTURING PROCESS

3.1 Manufacturing Flow Chart of Powder-Free Disposable Nitrile Gloves

Process – Procedure Inspection & Testing Procedure

Purchasing Material
Receiving Inspection
Receiving /
Handling, Storage Store

Compounding

Dipping
In Process Lab
Analysis
Production Process
Control
In Process Chemical
Analysis

Stripping QC Inspection

On-hold Area QA Pre-packing

Inspection

Handling, Storage,
Packaging,
Preservation and Storage
Delivery

Packing Packing QC Inspection

Pre-shipment Pre-Shipment QA Inspection

Inspection

Marketing Shipment

Confidential
 Revision No: 000
Technical File: PPE/PFN-B-MR/002 Effective Date: 10 Dec. 2010
Section 4.0: Quality Control System Page 1 of 2

SECTION 4.0 QUALITY CONTROL STSTEM

4.1 Incoming Material Inspection

4.1.1 All Incoming raw materials (that will affect the product’s quality) that are
subjected to inspection are placed under “Quarantine” area in the store.
4.1.2 Incoming materials are selected randomly as per ISO 2859 sampling plan and
inspected by Incoming Material Inspector.
4.1.3 Incoming materials that meet In-house specifications are attached with “Passed”
Sticker.
4.1.4 Incoming materials that do not meet In-house specifications are quarantined
pending management disposition decision.
• The Incoming materials are needed to be screened are attached with
“Rejected” Sticker and with “SCREEN” stamp on it.
• The Incoming materials that can be “Used as it” is (substandard material but
without functional implication and actual affect on quality) are attached with
“Rejected” Sticker and with “UAI” stamp on it.
• Incoming materials that cannot be used and needed to be returned back to
supplier are attached with “Reject” sticker “.
4.1.5 All Reject Materials are return immediately to Supplier or stored in “Reject
Area” pending return to supplier.

4.2 Milling and Compounding of Raw Material

4.2.1 Only the materials that with “Passed” Sticker can be used for milling process.
4.2.2 The milled chemical is analyzed by laboratory personnel.
4.2.3 Only the milled chemical that has passed laboratory analysis will be released to
be used in Compounding Process.
4.2.4 The milled chemical that has failed laboratory analysis shall be re-milled and
quarantined to be used until it passes laboratory analysis.
4.2.5 Only the approved milled chemicals and chemicals with “Passed” sticker are
used for compounding process.
4.2.6 The nitrile compounds are analyzed by laboratory personnel.
4.2.7 The nitrile compounds that pass all the In-house specification will be released
to be use in production.
4.2.8 The nitrile compounds that fail the In-house specification will be quarantined to
be used and shall wait for management disposition decision.
4.2.9 All adjustments made on the nitrile compounds will be documented in a work
sheet and shall be analyzed by laboratory personnel again.

4.3 Production On-line Goods

4.3.1 Each bin of gloves is issued with a Travel Card and is controlled to 8 kgs.
4.3.2 Samples are taken and inspected as per ISO 2859 table I and II-A.
4.3.3 Every 6 bins, grouped as one Lot shall be tested as follow;

Confidential
 Revision No: 000
Technical File: PPE/PFN-B-MR/002 Effective Date: 10 Dec. 2010
Section 4.0: Quality Control System Page 2 of 2

Inspect On Inspection Level AQL

i) Pin-hole 80 pcs 4.0
ii) Dimension S2 1.5
iii) Visual Major 80 pcs 4.0
iv) Visual Minor 80 pcs 6.5

4.3.4 The bins that have passed the above inspection will be marked as grade
AQL 4.0 on the Travel card.
4.3.5 The bins that had failed the above inspection will be segregated and
quarantined and stored in a specified area in store.
4.3.6 The passed bins will proceed to WIP Store or Packing Department.

4.4 Packing QC Inspection

4.4.1 At packing, Packing QC conduct line clearance inspection before commence
packing and at every hourly.
4.5 Finished Goods
4.5.1 The pallets of finish packed gloves are inspected by pre-shipment QA.
4.5.2 The samples are randomly picked and inspected as per ISO 2859 table I
and II-A for;

Inspect On Inspection Level AQL

i) Pin-hole (Watertight) S4 4.0
ii) Dimension S2 4.0
iii) Visual Major S4 4.0
iv) Visual Minor S4 6.5
v) pH of Glove N=3 -

4.5.3 The pallets of packed gloves that have passed Pre-shipment QA Inspection are
ready to deliver and store in outgoing store.
4.5.4 The pallets of packed gloves that have failed Pre-shipment QA Inspection shall
be reworked by Packing Department.
4.5.5 The sorted gloves will be quarantined and stored in specified area and wait for
management disposition decision.

Confidential
 Revision No: 000
Technical File: PPE/PFN-B-MR/002 Effective Date: 10 Dec. 2010
Section 5.0: Control and Test Facilities Page 1 of 1

SECTION 5.0 CONTROL AND TEST FACILITIES

5.1 Description of the Control and Test Facilities.

Area Control and Test Facilities

a) Laboratory 1) Chemical concentration testing apparatus.

b) Quality Control 1) Water-tight Test Equipment.

(QC) Section 2) Stainless Steel Ruler.
3) Thickness Gauge.

c) Pre-Packing QA 1) Water-tight Test Equipment.

Section 2) Stainless Steel Ruler.

d) Pre-shipment 1) Water-tight Test Equipment.

QA Section 2) Stainless Steel Ruler.
3) Thickness Gauge.

Confidential
 Revision No: 000
Technical File: PPE/PFN-B-MR/002 Effective Date: 10 Dec. 2010
Section 6.0: Product Testing Page 1 of 1

SECTION 6.0 PRODUCT TESTING

Tests were conducted to assure that the safe and correct operation of the product
maintained as well as achieving the performance and compatibilities as required by the
Directive. The test results include as attached:

• Skin Irritation Test

• Dermal Sensitization Test
• Chemical Residue Test
• Product Test Report

Confidential
 Revision No: 001
Technical File: PPE/PFN-B-MR/002 Effective Date: 29 Jun. 2011
Section 7.0: List of Pictogram Page 1 of 1

SECTION 7.0 LIST OF PICTOGRAMS (FOR LABELLING)

7.1 The Pictograms listed below can be replaced by suitable wordings, if necessary:

1) Keep away from moisture

2) Open packages
Keep away from heat (sunlight or fluorescence light).
3) Store at 10 to 40 °C

Lot No. of the PPE, e.g. 123456

Date of obsolescence, e.g. 2010-05

EN 374

Low Chemical Resistance and Water proof

Mark of conformity.
(minimum height 5mm)

7.2 Refer attachment for a sample of dispenser labeling.

Confidential
 Revision No: 001
Technical File: PPE/PFN-B-MR/002 Effective Date: 29 Jul 2011
Section 8.0: List of Applicable Standards Page 1 of 1

SECTION 8.0 LIST OF STANDARDS APPLIED

8.1 The referenced harmonized standards applied

• EN 374-1:2003, Protective gloves against chemicals and micro-organism -

Part 1: Terminology and performance requirements.

• EN 374-2:2003, Protective gloves against chemicals and micro-organism -

Part 2: Determination of resistance to penetration.

• EN 420: 2003 + A1: 2009, Protective gloves – General requirements and test
methods.

• EN 455-2: 2009 Medical gloves for single use - Part 2: Requirements and
testing for physical properties.

• EN 455-3:2006, Medical gloves for single use - Part 3: Requirements and

testing for biological evaluation.

• EN ISO 3071: 2006 Textiles – Determination of pH of aqueous extract.

• ISO 2859-1:1999, Sampling procedures for inspection by attributes - Part 1:

Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot
inspection.

• ISO 9001:2008, Quality management systems - Requirements.

(Certificate attached)

• ISO 10993-1: 2003, Biological evaluation of medical devices – Part:1

Evaluation and Testing.

• ISO 10993-10: 2002, Biological evaluation of medical devices – Part:10 Tests

for irritation and sensitization.

Confidential