FDA 510(k)
FDA class 1
Substantially Equivalent
🇲🇾 Malaysia
LATEX PATIENT EXAMINATION GLOVES
K Number: K896673
·
Decision Mar 8, 1990
Classifications
1
FEI Numbers
151
Registration Numbers
151
Same Product Code
1953
Applicant Total
12
Review Days
101
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Basic Information
- Device Name
- LATEX PATIENT EXAMINATION GLOVES
- K Number
- K896673
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6250
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Alliance Rubber Products Sdn. Bhd.
- Date Received
- November 27, 1989
- Decision Date
- March 8, 1990
- Product Code
- LYY
- Advisory Committee
- General Hospital
- 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 |
|---|---|---|---|
| LYY | Latex Patient Examination Glove | FDA class 1 | General Hospital |
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Other Clearances by Alliance Rubber Products Sdn. Bhd.
| K Number | Device Name | ||
|---|---|---|---|
| K002701 | POWDER FREE LATEX EXAMINATION GLOVES WITH WATER EXTRACTABLE PROTEIN LABELING CLAIM. (50 MICROGRAMS OR LESS) | Sep 13, 2000 | Substantially Equivalent |
| K992870 | POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES LABELING CONTENT: 100 MCGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEI | Oct 15, 1999 | Substantially Equivalent |
| K991981 | NITRILE EXAMINATION GLOVES, NON-STERILE, POWDER FREE, DARK BLUE COLOR | Aug 5, 1999 | Substantially Equivalent |
| K990485 | NITRILE EXAMINATION GLOVES, NON-STERILE, POWDERED, GREEN COLOR | Apr 23, 1999 | Substantially Equivalent |
| K990486 | NITRILE EXAMINATION GLOVES, NON-STERILE, POWDERED, BLUE COLOR. | Apr 23, 1999 | Substantially Equivalent |
| K990427 | ARSOFT NITRILE EXAMINATION GLOVES, NON-STERILE POWDER FREE | Apr 23, 1999 | Substantially Equivalent |
| K990453 | NITRILE EXAMINATION GLOVES, POWDER FREE, GREEN COLOR | Mar 9, 1999 | Substantially Equivalent |
| K983146 | ARSOFT | Dec 7, 1998 | Substantially Equivalent |
| K980589 | AR SAFE NITRILE EXAMINATION GLOVES | Apr 14, 1998 | Substantially Equivalent |
| K972801 | ALLIANCE RUBBER, EC-GRIP | Oct 21, 1997 | Substantially Equivalent |