Powder Free White Sterilized Polyisoprene Surgical Gloves-Tested for Use with The Chemotherapy Drugs
FDA 510(k) clearance K200915 · decided 2021-07-09
Clearance details
- K-number
- K200915
- Device name
- Powder Free White Sterilized Polyisoprene Surgical Gloves-Tested for Use with The Chemotherapy Drugs
- Applicant
- Gx Corporation Sdn Bhd
- Decision
- Substantially Equivalent
- Date received
- 2020-04-06
- Decision date
- 2021-07-09
- Days to decision
- 459 days
- Clearance type
- Traditional
- Product code
- KGO
- Device class
- 1
- Regulation number
- 878.4460
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Klang, MY
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.