FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BIOSHIELD BLUE POWDER FREE GLOVE
K Number: K940254
·
Decision Mar 23, 1994
Classifications
1
FEI Numbers
151
Registration Numbers
151
Same Product Code
1953
Applicant Total
11
Review Days
61
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Basic Information
- Device Name
- BIOSHIELD BLUE POWDER FREE GLOVE
- K Number
- K940254
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6250
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Chester Labs, Inc.
- Date Received
- January 21, 1994
- Decision Date
- March 23, 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 |
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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| K944600 | GRAHAM-FIELD SALINE ELECTROLYTE GEL | Nov 20, 1995 | Substantially Equivalent |
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| K944596 | GRAHAM-FIELD ULTRASOUND LOTION | Jun 7, 1995 | Substantially Equivalent |
| K940256 | BIOSHIELD BLUE LATEX GLOVES | Mar 23, 1994 | Substantially Equivalent |
| K841871 | LIQUA-SONIC GEL | Mar 14, 1985 | Substantially Equivalent |