FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
POLYKOTE
K Number: K953299
·
Decision Aug 7, 1995
Classifications
1
FEI Numbers
151
Registration Numbers
151
Same Product Code
1953
Applicant Total
6
Review Days
24
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Basic Information
- Device Name
- POLYKOTE
- K Number
- K953299
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6250
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Intl. Trade Management Co.
- Date Received
- July 14, 1995
- Decision Date
- August 7, 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 |
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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Other Clearances by Intl. Trade Management Co.
| K Number | Device Name | ||
|---|---|---|---|
| K954462 | POLYKOTE POWDER FREE STERILE LATEX SURGEONS GLOVES | Oct 13, 1995 | Substantially Equivalent |
| K951513 | JAI | May 25, 1995 | Substantially Equivalent |
| K950468 | POWDER FREE STERILE LATEX SURGEONS GLOVES | Apr 25, 1995 | Substantially Equivalent |
| K950467 | POWDER FREE PATIENT EXAMINATION GLOVES | Apr 25, 1995 | Substantially Equivalent |
| K946203 | JAI POWDERFREE LATEX EXAMINATION GLOVES | Feb 27, 1995 | Substantially Equivalent |