Wear Safe (Malaysia) Sdn. Bhd.
MalaysiaFDA applicant, unverified FDA FEI 3006552561
- Devices
- 14
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
What Wear Safe (Malaysia) Sdn. Bhd. makes
Wear Safe (Malaysia) Sdn. Bhd. manufactures medical gloves including latex and nitrile examination gloves, both powdered and powder-free, as well as sterile surgical gloves. Their products come in various colors such as blue and white, with some specifically tested for chemotherapy drugs and labeled for protein content.
The company's devices are classified as Class I and listed in the FDA 510(k) registry. Wear Safe (Malaysia) Sdn. Bhd. is based in the US.
Catalogue
Search and filter all 14 devicesCompany details
- FDA FEI number
- 3006552561
- Address
- LOT 13726,JALAN HAJI SALLEH, BATU 5 1/4, KLANG Selangor
FDA establishments
- Wear Safe (Malaysia) Sdn Bhd KLANG Selangor · MY FEI 3010602489
Frequently asked questions
How many devices does Wear Safe (Malaysia) Sdn. Bhd. have in the registry?
The registry currently lists 14 devices for Wear Safe (Malaysia) Sdn. Bhd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Wear Safe (Malaysia) Sdn. Bhd.'s devices?
Among its 14 most recently registered devices, Wear Safe (Malaysia) Sdn. Bhd. has devices listed in FDA 510(k) (14 devices).
What risk classes do Wear Safe (Malaysia) Sdn. Bhd.'s devices fall under?
Among its 14 most recently registered devices, the classes recorded for Wear Safe (Malaysia) Sdn. Bhd.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Wear Safe (Malaysia) Sdn. Bhd. in the registry?
The most recently registered devices listed for Wear Safe (Malaysia) Sdn. Bhd. include POWDER FREE NITRILE EXAMINATION GLOVES, WHITE (NON-COLORED) OR BLUE (COLORED), NON-STERILE, POWDER FREE LATEX EXAMINATION GLOVES BLUE (COLORED), NON-STERILE, WITH PROTEIN LABELING CLAIM OF 50UG PER DM2 OF GLOVE, POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVES, STERILE, WITH PROTEIN LABELING CLAIM OF 50 UG PER DM2 OF GLOVE and Sterile Powder Free Nitrile Surgical Glove, White Colored. Tested for Use with Chemotherapy Drugs, with Non-Pyrogenic Labeling Claim.
Which FDA establishments are linked to Wear Safe (Malaysia) Sdn. Bhd.?
1 FDA establishment is linked to Wear Safe (Malaysia) Sdn. Bhd. in the registry; they are listed on the company page.