FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CHEMO GLOVES POWDER FREE (MFG: UNION INDUSTRIAL)
K Number: K904130
·
Decision Oct 10, 1990
Classifications
1
FEI Numbers
151
Registration Numbers
151
Same Product Code
1953
Applicant Total
8
Review Days
35
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Basic Information
- Device Name
- CHEMO GLOVES POWDER FREE (MFG: UNION INDUSTRIAL)
- K Number
- K904130
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6250
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Biosafety Systems, Inc.
- Date Received
- September 5, 1990
- Decision Date
- October 10, 1990
- 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
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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 Biosafety Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K952274 | CHEMOGUARD, P2 HIRISK | Aug 29, 1995 | Substantially Equivalent |
| K944514 | P2 NITRILE EXAM GLOVES | Nov 28, 1994 | Substantially Equivalent |
| K944095 | P2 NITRILE EXAM GLOVES | Oct 28, 1994 | Substantially Equivalent |
| K944142 | P2 EXAM GLOVES | Oct 28, 1994 | Substantially Equivalent |
| K921313 | AEROSTAR | Sep 11, 1992 | Substantially Equivalent |
| K901411 | CHEMOPLUS GLOVE | Jun 7, 1990 | Substantially Equivalent |
| K900368 | P2/CHEMO PLUS GLOVES | Mar 8, 1990 | Substantially Equivalent |