FDA 510(k)
FDA class 1
Substantially Equivalent
🇲🇾 Malaysia
COMFIT EXAMINATION GLOVES, POWDER FREE, HYPOALLERGENIC
K Number: K942947
·
Decision Nov 30, 1994
Classifications
1
FEI Numbers
151
Registration Numbers
151
Same Product Code
1953
Applicant Total
61
Review Days
160
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Basic Information
- Device Name
- COMFIT EXAMINATION GLOVES, POWDER FREE, HYPOALLERGENIC
- K Number
- K942947
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6250
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Wembley Rubber Products (M) Sdn Bhd
- Date Received
- June 23, 1994
- Decision Date
- November 30, 1994
- 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 Wembley Rubber Products (M) Sdn Bhd
| K Number | Device Name | ||
|---|---|---|---|
| K982600 | PROFEEL SYNTHETIC COPOLYMER SURGICAL GLOVES (POWDERED) | Mar 12, 1999 | Substantially Equivalent |
| K972616 | ONCOLOGY PLUS POWDER FREE LATEX EXAMINATION GLOVES (PROTEIN CONTENT LABELING) | Jan 27, 1999 | Substantially Equivalent |
| K972615 | CHEMO PLUS POWDER FREE BLUE LATEX EXAMINATION GLOVES (PROTEIN CONTENT LABELING) | Jan 26, 1999 | Substantially Equivalent |
| K972621 | PROFEEL POWDER FREE SURGICAL GLOVES (PROTEIN CONTENT LABELING) | Oct 24, 1997 | Substantially Equivalent |
| K953213 | COMFIT (POWDER FREE EXAMINATION GLOVES (HYPOALLERGENIC, LOW PROTEIN, BEADED) | Oct 11, 1996 | Substantially Equivalent |
| K962189 | COMFIT POWDER FREE GREEN EXAMINATION GLOVES (HYPOALLERGENIC, LOW PROTEIN) | Jul 26, 1996 | Substantially Equivalent |
| K962188 | COMFIT POWDER FREE BLUE EXAMINATION GLOVES (HYPOALLERGENIC, LOW PROTEIN) | Jul 26, 1996 | Substantially Equivalent |
| K953590 | COMFIT | Jun 27, 1996 | Substantially Equivalent |
| K960178 | COMFIT BROWN, BEADED SURGEON'S GLOVES (POWDERED, HYPOALLERGENIC) | May 6, 1996 | Substantially Equivalent |
| K960407 | COMFIT ORTHOPEDIC | Apr 26, 1996 | Substantially Equivalent |