Data / Medical devices / Malaysia / Wear Safe (malaysia) Sdn Bhd
Wear Safe (malaysia) Sdn Bhd: FDA-registered device maker in KLANG Selangor, Malaysia, 4 510(k) clearances
Wear Safe (malaysia) Sdn Bhd is registered with the FDA (registration 3010602489) in KLANG Selangor, Malaysia. It lists 6 device types. The FDA files 4 510(k) clearances under its listings, the newest dated September 29, 2017. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3010602489
- Address
- Lot 5068 & 5069, Batu 4 ½ Jalan Meru, KLANG Selangor, Malaysia, 41050
- Owner or operator
- WEAR SAFE (MALAYSIA) SDN BHD (9066807)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- February 5, 2009
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Fentanyl And Other Opioid Protection Glove | QDO | 1 | Contract manufacturer | accessdata.fda.gov |
| Latex Patient Examination Glove | LYY | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Medical Glove, Specialty | LZC | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | 1 | Contract manufacturer | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Surgeon'S Gloves | KGO | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 29, 2017 | K172420 | Sterile Powder Free Nitrile Surgical Glove, White Colored. Tested for Use with Chemotherapy Drugs, with Non-Pyrogenic Labeling Claim | KGO | Substantially Equivalent | Wear Safe (Malaysia) Sdn. Bhd. | accessdata.fda.gov |
| May 15, 2009 | K090066 | POWDER FREE POLYMER COATED LATEX SURGICAL GLOVES, STERILE, WITH PROTEIN LABELING CLAIM OF 50 MICROGRAMS PER DM2 OF GLOVE | KGO | Substantially Equivalent | Wear Safe (Malaysia) Sdn. Bhd. | accessdata.fda.gov |
| April 3, 2009 | K090327 | POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVES, STERILE, WITH PROTEIN LABELING CLAIM OF 50 UG PER DM2 OF GLOVE | LYY | Substantially Equivalent | Wear Safe (Malaysia) Sdn. Bhd. | accessdata.fda.gov |
| October 27, 2006 | K062778 | STERILE POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED | LZA | Substantially Equivalent | Wear Safe Malaysia Sdn. Bhd. | accessdata.fda.gov |
Compare with other makers
- All makers of Polymer Patient Examination Glove
- All makers of Medical Glove, Specialty
- All makers of Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs
- All makers of Surgeon'S Gloves
- All makers of Latex Patient Examination Glove
- All makers of Fentanyl And Other Opioid Protection Glove
Updated September 29, 2017. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.