FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CARETOUCH EXAMINATION GLOVES
K Number: K892580
·
Decision Jul 14, 1989
Classifications
1
FEI Numbers
151
Registration Numbers
151
Same Product Code
1953
Applicant Total
15
Review Days
95
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Basic Information
- Device Name
- CARETOUCH EXAMINATION GLOVES
- K Number
- K892580
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6250
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- James River Corp.
- Date Received
- April 10, 1989
- Decision Date
- July 14, 1989
- 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 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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Other Clearances by James River Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K894505 | COTOLIN DRAIN SPONGE AND DRESSING SPONGE | Sep 15, 1989 | Substantially Equivalent |
| K894147 | VISULIN TRANSPARENT ADHESIVE DRESSING | Aug 9, 1989 | Substantially Equivalent for Some Indications |
| K893939 | ISOLATION MASKS | Jul 14, 1989 | Substantially Equivalent |
| K894034 | MODIFIED LABELING OF SURGICAL GLOVES | Jul 14, 1989 | Substantially Equivalent |
| K890459 | JAMES RIVER BIOGEL POWDERLESS SURGICAL GLOVES | Apr 20, 1989 | Substantially Equivalent |
| K883802 | CARETEX CENTRAL SUPPLY WRAP | Oct 21, 1988 | Substantially Equivalent |
| K884112 | CARETEX OR TOWEL | Oct 13, 1988 | Substantially Equivalent |
| K883657 | SKID RESISTANT, LONG LASTING SHOE COVERS | Sep 15, 1988 | Substantially Equivalent |
| K880431 | CARETEX SURGEON'S HOODS | Feb 24, 1988 | Substantially Equivalent |
| K880481 | CARETEX SURGEON'S CAPS | Feb 24, 1988 | Substantially Equivalent |