To ensure safety, the Philippines FDA will ban powdered medical gloves and have advised the general public, including all healthcare professionals, that powdered gloves will be phased out by the end of 2018 in favor of powder-free medical gloves.
The Philippines Food and Drug Administration (FDA) has released Advisory No. 2017-180, dated June 20, 2017, which covers the risks posed by the following powdered medical gloves:
- Powdered Surgeon’s Gloves
- Powdered Patient Examination Gloves
- Absorbable Powder for Lubricating a Surgeon’s Gloves
This advisory is based on the US Food and Drug Administration (USFDA) Medical Device Bans DN: 2016-30382, that the powdered medical gloves “present an unreasonable and substantial risk of illness or injury, and that the risk cannot be corrected or eliminated by labelling or a change in labelling”. The health authority cited potential consequences including inflammation, granulomas, and respiratory allergic reactions.
Following the USFDA ban of powdered medical gloves, the Philippines FDA shall adopt the use of powder-free medical gloves and has advised the general public, including all healthcare professionals, that the powdered medical gloves will be gradually phased out by the end of 2018. Please be advised that the advisory does not apply to powdered radiographic protection gloves; powder used in the manufacturing process of non-powdered gloves, and powder intended for use in or on other medical devices such as condoms.
Effective 1st January 2019, all applications for product certifications and/or other authorizations for powdered gloves will no longer be accepted. All valid Certificate of Product Registration (CPRs) issued prior to December 31, 2018 will automatically be revoked, terminated or cancelled due to the potential danger posed to clinicians and the general public. The importation, sale, manufacture or distribution of abovementioned medical devices will be prohibited from the 31st December 2018. Any infringement will be considered as a direct violation of Republic Act. No. 9711 or the Food and Drug Administration Act of 2009.
For assistance on registering your medical device in the Philippines please contact sales@andamanmed.com