FDA 510(k)
FDA class 1
Substantially Equivalent
🇲🇾 Malaysia
CASHMERE NON-STERILE POWDERED NITRILE EXAMINATION GLOVES BLUE AND GREEN
K Number: K993133
·
Decision Nov 17, 1999
Classifications
1
FEI Numbers
380
Registration Numbers
380
Same Product Code
1171
Applicant Total
13
Review Days
58
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Basic Information
- Device Name
- CASHMERE NON-STERILE POWDERED NITRILE EXAMINATION GLOVES BLUE AND GREEN
- K Number
- K993133
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6250
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Seal Polymer Industries Bhd.
- Date Received
- September 20, 1999
- Decision Date
- November 17, 1999
- Product Code
- LZA
- 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 |
|---|---|---|---|
| LZA | Polymer Patient Examination Glove | FDA class 1 | General Hospital |
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Other Clearances by Seal Polymer Industries Bhd.
| K Number | Device Name | ||
|---|---|---|---|
| K042238 | CASHMERE POLYMER COATED POWDER FREE NITRILE EXAMINATION GLOVES | Sep 16, 2004 | Substantially Equivalent |
| K042101 | CASHMERE POWDER FREE NITRILE EXAMINATION GLOVES | Aug 27, 2004 | Substantially Equivalent |
| K032077 | CASHMERE NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES (VIOLET) | Aug 19, 2003 | Substantially Equivalent |
| K022792 | CASHMERE POWDER FREE LATEX EXAMINATION GLOVES (POLYMER COATED ONLINE CHLORINATED) | Sep 26, 2002 | Substantially Equivalent |
| K021388 | CASHMERE NON-STERILE, POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES CONTAINS 50 MCGM OR LESS OF TOTAL WATER EXTRAM | Jun 10, 2002 | Substantially Equivalent |
| K020868 | CASHMERE NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES (WHITE) | Apr 22, 2002 | Substantially Equivalent |
| K014055 | NON-STERILE POWDERED LATEX EXAMINATION GLOVES WITH A PROTEIN CLAIM ON LABELING | Jan 28, 2002 | Substantially Equivalent |
| K993326 | NON-STERILE POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES WITH A PROTEIN LABELING CLAIM (70 MICROGRAMS OR LESS PER | Nov 17, 1999 | Substantially Equivalent |
| K993134 | CASHMERE NON-STERILE BLUE POWDERED NITRILE EXAMINATION GLOVESBLUE AND GREEN) | Nov 17, 1999 | Substantially Equivalent |
| K991849 | NON-STERILE POWDER-FREE LATEX EXAMINATION GLOVES WITH A PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS TOTAL WATER EXTRAC | Jul 7, 1999 | Substantially Equivalent |