FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SUTURE WOUND TRAY MILFORD WHITTINSVILLE
K Number: K802386
·
Decision Nov 12, 1980
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
33
Applicant Total
33
Review Days
41
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Basic Information
- Device Name
- SUTURE WOUND TRAY MILFORD WHITTINSVILLE
- K Number
- K802386
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6250
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- American Medical Disposable, Inc.
- Date Received
- October 2, 1980
- Decision Date
- November 12, 1980
- Product Code
- FMC
- 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 |
|---|---|---|---|
| FMC | Patient Examination Glove | FDA class 1 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FMC), ordered by most recent decision date.
LAGLOVE BRAND DOUBLE POLYMER COATED NITRILE EXAMINATION GLOVES (POWDER FREE - BLUE COLOR)
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FDA Class 1
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POWDER-FREE LATEX EXAM GLOVES WITH PROTEIN LABELING (<50UG/G)
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BLOSSOM POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM 50 MCGM OR LESS OF TOTAL WATER EXTRACTA
FDA 510(k)
FDA Class 1
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NITRILE RUBBER POWDER-FREE EXAMINATION GLOVE
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FDA Class 1
·General Hospital
NITRILE RUBBER EXAMINATION GLOVES (POWERED)
FDA 510(k)
FDA Class 1
·General Hospital
SURGICAL INSTRUMENT KIT, DISPOSABLE
FDA 510(k)
FDA Class 1
·General Hospital
Other Clearances by American Medical Disposable, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K833734 | NEUROLOGICAL SPONGE ON PLASTIC STICK | Apr 23, 1984 | Substantially Equivalent |
| K833735 | AN ODOR ABSORBENT BANDAGE | Apr 23, 1984 | Substantially Equivalent |
| K833730 | NON ADHERENT BANDAGE/SHEET | Jan 27, 1984 | Substantially Equivalent |
| K833731 | BREATHABLE OVERWRAY BANDAGE NON-ELAS | Jan 27, 1984 | Substantially Equivalent |
| K833729 | ELASTIC BREATHABLE OVER-WRAP BANDAGE | Dec 30, 1983 | Substantially Equivalent |
| K833733 | NON - ADHERENT BANDAGE | Dec 27, 1983 | Substantially Equivalent |
| K833732 | NON WETTING UNDERCAST PADDING | Dec 12, 1983 | Substantially Equivalent |
| K830201 | POLYESTER X-RAY DETECTABLE STRUNG-SPONGE | Feb 23, 1983 | Substantially Equivalent |
| K830202 | COTTON BALLS, X-RAY OPAQUED STRUNG & NON | Feb 23, 1983 | Substantially Equivalent |
| K803116 | HEAVY DRAINAGE PACK | Jan 28, 1981 | Substantially Equivalent |