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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 notifikasi 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

 No

Product Name

Description

Medical device/not

1

KN95, FFP2, N95, surgical face mask

To be used by healthcare professional during procedures to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material

Medical device if it is for surgical use

Not a medical device if it is not for surgical use

GLOVE

 No

Product Name

Description

Medical device/not

5

Surgical glove

To be worn during an invasive surgery, in order to prevent cross contamination between healthcare personnel and patient

Medical device

 

6

Examination glove

A two-way protective barrier during medical procedure and examination by healthcare personnel

Medical device

7

Disposable glove

To protect hands from messy or skin irritating tasks or to protect hands from germs, perspiration

Not a medical device

OVERALL CLOTHING

 No

Product Name

Description

Medical device/not

8

Disposable protective overall clothing (isolation gown)

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

Medical device if it is for surgical use

Not a medical device if it is not for surgical use

9

Medical disposable protective clothing

10

Surgical gown

To be used as protective apparel during surgical procedures

Medical device

11

Disposable plastic apron

A non-sterile, single-use, disposable apron, protect clothing and skin against spills

Not a medical device

GOOGLES OR FACESHIELD

 No

Product Name

Description

Medical device/not

12

Safety goggles

Anti-fog/medical goggles for hospital, against droplets/saliva & splashes of liquids

Not a medical device

13

Face shield

Designed for procedures and environments where risk of exposure to blood and/or bodily fluids through splashing is possible

Medical device if it is for surgical use

Not a medical device if it is not for surgical use

SHOE/HEAD COVER

 No

Product Name

Description

Medical device/not

14

Disposable shoe cover

To cover shoes to prevent spreading of dirt in operation theater or surgical room

Medical device

Barrier against dirt and low-risk contaminants where shoes or floors need protection from contamination, spills and splashes

Not a medical device

  15

Head cover/surgical cap

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

Medical device

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

Not a medical device

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  Medical Device Authority (MDA),
Ministry of Health Malaysia,
Level 6, Prima 9, Prima Avenue II,
Block 3547, Persiaran APEC,
63000 Cyberjaya, Selangor, MALAYSIA

  +603 - 8230 0300
  +603 - 8230 0200 
  mdb@mda.gov.my

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  • Last Modified: 08 October 2020.
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