MAKLUMAT TAMBAHAN MENGENAI PERALATAN PERLINDUNGAN DIRI (PERSONAL PROTECTIVE EQUIPMENT — PPE) MAKLUMAT TAMBAHAN MENGENAI PERALATAN PERLINDUNGAN DIRI (PERSONAL PROTECTIVE EQUIPMENT — PPE) ‘Susulan daripada pengumuman berkaitan pengimportan, penjualan dan pengedaran peralatan perlindungan diri (personal protective equipment — PPE), PBPP telah menerima pertanyaan memohon penjelasan mengenai perkara ini. Sehubungan itu, PBPP ingin menjelaskan bahawa PPE yang tidak memerlukan kelulusan atau kebenaran PBPP adalah PPE yang tidak diklasifikasikan sebagai peranti perubatan. Manakala PPE yang diklasifikasikan sebagai peranti perubatan memerlukan kelulusan PBPP sebelum pengimportan, penjualan, dan pengedaran. Walau bagaimanapun, bagi memastikan capaian peranti perubatan tidak terganggu semasa penularan wabak Covid-19, mana-mana pihak yang ingin mengimport atau mengedarkan PPE yang diklasifikasikan sebagai peranti perubatan boleh membuat notifkasi untuk pengecualian daripada pendaftaran bagi meletakkannya dalam pasaran melalui akses khas (special access). Berikut adalah jadual yang memberi penjelasan sama ada sesuatu produk PPE diklasifikasikan peranti perubatan (dan memerlukan kelulusan atau kebenaran PBPP) atau bukan peranti perubatan (dan tidak memerlukan kebenaran atau kelulusan PBPP)}— mask Medical No Product Nz Descripti Jo Product Name fescription devicenot Medical device itt ‘sed by healthcare professional during procedures to protet 1 patient 8 for surgical use kgs, FEP2, ngs, 72 08 used by healthcare professional during procedures to protect both the patient and healthcare personnel from transfer of microorganisms, body Nuids, and surgical face mask Pe 9 vy Not a medical particulate material device ifitis not for surgical use GLOVE Medical NoProductName Description in device/not To be wor during an invasive surgery, in order to prevent cross contamination Medical device 5 Surgical gl wrgical love petween healthcare personnel and pationt A two-way protective barrier during medical procedure and examination by healthcare personnel 6 Examination glove Medical device To protect hands from messy or skin iritating tasks or to protect hands from germs, Not a medical 7 Disposable gloves repiration device OVERALL CLOTHING Medical No Product Ni Descripti fo Product Name jescription deviewnot8 10 Disposable protective overall clothing {isolation gown) Medical disposable protective clothing ‘Surgical gown Disposable plastic apron ‘No Product Name 12 13 Safety goggles Face shiold No Product Name 14 18 Disposable shoe Head cover/surgical cap A good permeability to effectively resist penetration of bacteria, viruses, alcohol, blood, body fluids, air dust particles, and protect the wearer from the threat of infection To be used as protective apparel during surgical procedures Annon-sterile, single-use, disposable apron, protect clothing and skin against spills GOOGLES OR FACESHIELD Description Anti-fog/medical goggles for hospital, against droplets/saliva & splashes of liquids Designed for procedures and environments where risk of exposure to blood and/or bodily fluids through splashing is possible SHOE/HEAD COVER Description To cover shoes to prevent spreading of dir in operation theater or surgical room Barrier against dirt and low-risk contaminants where shoes or floors need protection from contamination, spills and splashes Barrier against microorganisms that emerge from hair that can cause pollution during surgery and to protect medical personnel from infective agents and splashes of potentially contaminated liquids and particles To cover hair and ear that may pose a threat to the patient due to the risk of foreign particles falling into the medical procedure side when procedure in order. Not used in the operation room Medical device itt is for surgical use Not a medical device if it is not for surgical use Medical device Not a medical device Medical dovice/not Not a medical device Medical device itt is for surgical use Not a medical device if itis not for surgical use Medical device/not Medical device Not a medical device Medical device Not a medical device