PATIENT EXAMINATION GLOVES (LATEX)
FDA 510(k) clearance K892791 · decided 1989-08-24
Clearance details
- K-number
- K892791
- Device name
- PATIENT EXAMINATION GLOVES (LATEX)
- Applicant
- Union Industrial Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1989-04-11
- Decision date
- 1989-08-24
- Days to decision
- 135 days
- Clearance type
- Traditional
- Product code
- IMM
- Device class
- 1
- Regulation number
- 890.3920
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Bangkrut Pha Smutpar, TH
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| EZ STAND MOBILE STOOL (K821634) | Fred Sammons, Inc. | 1982-06-11 |
Recalls involving this device
No recalls on record reference this clearance.