FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
LATEX SURGEON SURGEON'S GLOVES POWDER-FREE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
K Number: K001274
·
Decision Jun 23, 2000
Classifications
1
FEI Numbers
143
Registration Numbers
143
Same Product Code
556
Applicant Total
5
Review Days
64
Basic Information
- Device Name
- LATEX SURGEON SURGEON'S GLOVES POWDER-FREE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
- K Number
- K001274
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4460
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- P.T. MAJA AGUNG LATEXINDO
- Date Received
- April 20, 2000
- Decision Date
- June 23, 2000
- Product Code
- KGO
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KGO | Surgeon'S Gloves | FDA class 1 | General, Plastic Surgery |
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Other Clearances by P.T. MAJA AGUNG LATEXINDO
| K Number | Device Name | ||
|---|---|---|---|
| K994255 | LATEX EXAMINATION GLOVES-PRE-POWDERED-STERILE | Feb 7, 2000 | Substantially Equivalent |
| K992752 | SURGEON'S GLOVES PRE-POWDERED, MODELS 6.5, 7, 7.5, 8, 8.5 | Nov 5, 1999 | Substantially Equivalent |
| K982897 | POWDER FREE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) | Dec 23, 1998 | Substantially Equivalent |
| K896604 | MAL LATEX EXAMINATION GLOVES | Jan 2, 1990 | Substantially Equivalent |