TG MEDICAL POWDER-FREE LATEX EXAMINATION GLOVE PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)
FDA 510(k) clearance K982872 · decided 1998-10-15
Clearance details
- K-number
- K982872
- Device name
- TG MEDICAL POWDER-FREE LATEX EXAMINATION GLOVE PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)
- Applicant
- Tg Medical Sdn. Bhd.
- Decision
- Substantially Equivalent
- Date received
- 1998-08-14
- Decision date
- 1998-10-15
- Days to decision
- 62 days
- Clearance type
- Traditional
- Product code
- LYY
- Device class
- 1
- Regulation number
- 880.6250
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Klang, Selangor D.E., MY
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Powder Free Latex , Non-sterile Medical Exam Gloves Cat #s: 22401 22402 22403 and 22404 recall (Z-0909-06) | Gulf South Medical Supply Inc | 2006-05-25 |