LATEX EXAMINATION GLOVES(MFG: MODLOOK INDUSTRIES)
FDA 510(k) clearance K904641 · decided 1990-10-19
Clearance details
- K-number
- K904641
- Device name
- LATEX EXAMINATION GLOVES(MFG: MODLOOK INDUSTRIES)
- Applicant
- Predex Co. , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1990-10-11
- Decision date
- 1990-10-19
- Days to decision
- 8 days
- Clearance type
- Traditional
- Product code
- LYY
- Device class
- 1
- Regulation number
- 880.6250
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Taipei, Taiwan, R.O.C., CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.