STERILE POWDERED LATEX SURGICAL GLOVES WITH PROTEIN LABELING CLAIM (200 MICROGRAMS OR LESS)
FDA 510(k) clearance K012896 · decided 2001-11-16
Clearance details
- K-number
- K012896
- Device name
- STERILE POWDERED LATEX SURGICAL GLOVES WITH PROTEIN LABELING CLAIM (200 MICROGRAMS OR LESS)
- Applicant
- Ssn Gloves (M) Sdn Bhd
- Decision
- Substantially Equivalent
- Date received
- 2001-08-28
- Decision date
- 2001-11-16
- Days to decision
- 80 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
- Petaling Jaya, Selangor, MY
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.