FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SAFETEX SUPER HYPERALLERGENIC POWDERFREE LATEX MEDICAL GLOVE
K Number: K952404
·
Decision Jul 20, 1995
Classifications
1
FEI Numbers
151
Registration Numbers
151
Same Product Code
1953
Applicant Total
18
Review Days
59
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Basic Information
- Device Name
- SAFETEX SUPER HYPERALLERGENIC POWDERFREE LATEX MEDICAL GLOVE
- K Number
- K952404
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6250
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Aladan Corp.
- Date Received
- May 22, 1995
- Decision Date
- July 20, 1995
- 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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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 Aladan Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K960590 | TRI-CLEAN 110/TRI-CLEAN PLUS GLOVE | Oct 31, 1996 | Substantially Equivalent |
| K952556 | SAFETEX SUPER HYPOALLERGENIC POWDERED LATEX EXAMINATION GLOVE | Jun 26, 1995 | Substantially Equivalent |
| K943933 | SAXON GOLD ULTRA SPERMICIDAL RAINBOW CONDOM | Jun 22, 1995 | Substantially Equivalent |
| K951839 | ALADAN HYPOALLERGENIC LATEX MEDICAL EXAMINATION GLOVES | Jun 15, 1995 | Substantially Equivalent |
| K943883 | SAXON GOLD ULTRA SPERMICIDAL RAINBOW CONDOM | Apr 14, 1995 | Substantially Equivalent |
| K942758 | HYPOALLERGEN NON-STER POWDERFREE LATEX PAT EXAM GLOVE | Jul 8, 1994 | Substantially Equivalent |
| K940873 | SAFETEX HYPOALLERGENIC POWDERFREE LATEX EXAMINATION GLOVE | Apr 22, 1994 | Substantially Equivalent |
| K911774 | ALADAN LATEX MEDICAL GLOVE | May 3, 1991 | Substantially Equivalent |
| K911447 | LATEX EXAMINATION GLOVES (HYPOALLERGENIC) | Apr 16, 1991 | Substantially Equivalent |
| K905279 | CONDOM (RUBBER) CONTRACEPTIVE | Feb 19, 1991 | Substantially Equivalent |