Powder-Free Polyisoprene Sterile Surgical Gloves in White Color Tested for Use with Chemotherapy Drugs, Powder-Free Polyisoprene Sterile Surgical Gloves in Green Color.
FDA 510(k) clearance K142941 · decided 2015-11-02
Clearance details
- K-number
- K142941
- Device name
- Powder-Free Polyisoprene Sterile Surgical Gloves in White Color Tested for Use with Chemotherapy Drugs, Powder-Free Polyisoprene Sterile Surgical Gloves in Green Color.
- Applicant
- Pt. Medisafe Technologies
- Decision
- Substantially Equivalent
- Date received
- 2014-10-09
- Decision date
- 2015-11-02
- Days to decision
- 389 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
- Tanjung Morawa, Medan, ID
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Cont recall (Z-1725-2026) | Medline Industries, LP | 2026-04-07 |