FDA 510(k)
FDA class 1
Substantially Equivalent
🇲🇾 Malaysia
POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABEL CLAIM CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER LABEL CLAIM
K Number: K000667
·
Decision Apr 28, 2000
Classifications
1
FEI Numbers
151
Registration Numbers
151
Same Product Code
1953
Applicant Total
5
Review Days
60
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Basic Information
- Device Name
- POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABEL CLAIM CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER LABEL CLAIM
- K Number
- K000667
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6250
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Protection Gloves Sdn. Bhd.
- Date Received
- February 28, 2000
- Decision Date
- April 28, 2000
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LYY), ordered by most recent decision date.
Powder Free Natural Rubber Latex Examination Gloves Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less Protein
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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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Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L)
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Powder-Free Latex examination gloves
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Non Sterile Powder Free Latex Examination Glove
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Other Clearances by Protection Gloves Sdn. Bhd.
| K Number | Device Name | ||
|---|---|---|---|
| K010854 | CHLORINATED POWDER-FREE LATEX EXAMINATION GLOVES, (BLUE, GREEN) | Jun 13, 2001 | Substantially Equivalent |
| K011231 | CHLORINATED POWDERED LATEX EXAMINATION GLOVES, BLUE, GREEN | Jun 13, 2001 | Substantially Equivalent |
| K000668 | POWDER-FREE NON-VHLORINATED POLYMER COATED LATEX EXAMINATION GLOVES CONTAINS 100 MICROGRAMS OR LESS OF TOTAL WATER EXTRA | Apr 28, 2000 | Substantially Equivalent |
| K945164 | MULTIPLE | Feb 3, 1995 | Substantially Equivalent |