FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PREPOWDERED VINYL EXAM GLOVES
K Number: K893334
·
Decision Aug 15, 1989
Classifications
1
FEI Numbers
131
Registration Numbers
131
Same Product Code
798
Applicant Total
19
Review Days
117
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Basic Information
- Device Name
- PREPOWDERED VINYL EXAM GLOVES
- K Number
- K893334
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6250
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Dynarex Corp.
- Date Received
- April 20, 1989
- Decision Date
- August 15, 1989
- Product Code
- LYZ
- 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 |
|---|---|---|---|
| LYZ | Vinyl Patient Examination Glove | FDA class 1 | General Hospital |
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|---|---|---|---|
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| K012917 | DYNAREX UMBILICAL CORD LAMP, MODELS 6833 AND 6833-B | Nov 28, 2001 | Substantially Equivalent |
| K991695 | DYNAREX NON-WOVEN SPONGE | Jul 15, 1999 | Substantially Equivalent |
| K991694 | DYNAREX DRAIN SPONGE | Jul 15, 1999 | Substantially Equivalent |
| K983348 | DYNAREX TRACHEOSTOMY SPONGE | Dec 11, 1998 | Substantially Equivalent |
| K960388 | DYNAREX NON-WOVEN SPONGE | Apr 1, 1996 | Substantially Equivalent |
| K951660 | DYNAREX GAUZE SPONGE | May 9, 1995 | Substantially Equivalent |