ALOETOUCH POWDER FREE, POLYMER COATED POLYISOPRENE SURGICAL GLOVES, STERILE, COATED WITH ALOE VERA, NATURAL COLOUR
FDA 510(k) clearance K040503 · decided 2004-03-16
Clearance details
- K-number
- K040503
- Device name
- ALOETOUCH POWDER FREE, POLYMER COATED POLYISOPRENE SURGICAL GLOVES, STERILE, COATED WITH ALOE VERA, NATURAL COLOUR
- Applicant
- Wrp Asia Pacific Sdn. Bhd.
- Decision
- Substantially Equivalent
- Date received
- 2004-02-27
- Decision date
- 2004-03-16
- Days to decision
- 18 days
- Clearance type
- Special
- Product code
- KGO
- Device class
- 1
- Regulation number
- 878.4460
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Sepang, MY
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Sensicare Green Surgical Glove, PI, LF, PF. Packaged in a poly/poly peel pouch with Sunoco recall (Z-0162-2018) | Medline Industries Inc | 2017-11-21 |