Polychloroprene Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Fusion Colour)
FDA 510(k) clearance K211758 · decided 2021-08-03
Clearance details
- K-number
- K211758
- Device name
- Polychloroprene Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Fusion Colour)
- Applicant
- Hartalega NGC Sdn. Bhd.
- Decision
- Substantially Equivalent
- Date received
- 2021-06-07
- Decision date
- 2021-08-03
- Days to decision
- 57 days
- Clearance type
- Traditional
- Product code
- OPC
- Device class
- 1
- Regulation number
- 880.6250
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Sepang, MY
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Hartalega NGC Sdn. Bhd.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Recalls involving this device
No recalls on record reference this clearance.