FDA 510(k)
FDA class 1
Substantially Equivalent
🇲🇾 Malaysia
POWDERFREE LATEX EXAMINATION GLOVES (POLYMER COATED) (PROTEIN LABEL OF 50 MCROGRAM OR LESS)
K Number: K993500
·
Decision Dec 2, 1999
Classifications
1
FEI Numbers
151
Registration Numbers
151
Same Product Code
1953
Applicant Total
22
Review Days
48
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Basic Information
- Device Name
- POWDERFREE LATEX EXAMINATION GLOVES (POLYMER COATED) (PROTEIN LABEL OF 50 MCROGRAM OR LESS)
- K Number
- K993500
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6250
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Besglove Medicare Sdn. Bhd.
- Date Received
- October 15, 1999
- Decision Date
- December 2, 1999
- 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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Powder Free Latex Patient Examination Glove, Black Colored, Non-sterile, with Protein Content labeling Claim (Contains 50 ug per dm2 of glove or less of Total Water Extractable Protein)
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Other Clearances by Besglove Medicare Sdn. Bhd.
| K Number | Device Name | ||
|---|---|---|---|
| K994082 | POWDERED LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM) (50 MICROGRAM OR LESS) | Jan 28, 2000 | Substantially Equivalent |
| K993495 | POWDERED LATEX EXAMINATION GLOVES(PROTEIN LABEL CLAIM 150 MICROGRAMS OR LESS) | Nov 24, 1999 | Substantially Equivalent |
| K993502 | POWDERFREE LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM 50 MICROGRAMS OR LESS) | Nov 24, 1999 | Substantially Equivalent |
| K981877 | NITRILE POWDERFREE EXAMINATION GLOVES | Aug 11, 1998 | Substantially Equivalent |
| K981878 | POWDERFREE NITRILE EXAMINATION GLOVES (POLYMER COATED) | Aug 11, 1998 | Substantially Equivalent |
| K981879 | POWDERED NITRILE EXAMINATION GLOVES | Aug 11, 1998 | Substantially Equivalent |
| K982286 | POWDERFREE GREEN LATEX EXAMINATION GLOVES (POLYMER COATED) | Aug 11, 1998 | Substantially Equivalent |
| K982285 | POWDERFREE GREEN LATEX EXAMINATION GLOVES | Aug 3, 1998 | Substantially Equivalent |
| K982284 | POWDERED GREEN LATEX EXAMINATION GLOVES | Aug 3, 1998 | Substantially Equivalent |
| K981673 | POWDERFREE GREEN NITRILE EXAMINATION GLOVES | Jul 28, 1998 | Substantially Equivalent |