FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
STERILE POWDER FREE SYNTHETIC VINYL PATIENT EXAM GLOVE
K Number: K012282
·
Decision Aug 6, 2001
Classifications
1
FEI Numbers
131
Registration Numbers
131
Same Product Code
798
Applicant Total
26
Review Days
17
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- STERILE POWDER FREE SYNTHETIC VINYL PATIENT EXAM GLOVE
- K Number
- K012282
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6250
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Cypress Medical Products, Ltd.
- Date Received
- July 20, 2001
- Decision Date
- August 6, 2001
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LYZ), ordered by most recent decision date.
Powder Free Synthetic Vinyl Exam Gloves (Blue, Black)
FDA 510(k)
FDA Class 1
·General Hospital
Disposable Vinyl Examination Gloves
FDA 510(k)
FDA Class 1
·General Hospital
Powder-Free Vinyl Exam Gloves, clear
FDA 510(k)
FDA Class 1
·General Hospital
Disposable Vinyl Examination Gloves
FDA 510(k)
FDA Class 1
·General Hospital
Vinyl examination gloves
FDA 510(k)
FDA Class 1
·General Hospital
Disposable Powder Free Vinyl Examination Gloves, Beige/Clear
FDA 510(k)
FDA Class 1
·General Hospital
Other Clearances by Cypress Medical Products, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K021676 | CYPRESS MEDICAL PRODUCTS, LP DISPOSABLE VAGINAL SPECULUM, NON-METAL | Jul 12, 2002 | Substantially Equivalent |
| K972899 | CYPRESS MEDICAL PRODUCTS ANEROID SPHYGMOMANOMETER | Jul 7, 1998 | Substantially Equivalent |
| K972849 | ISOSAFE EARLOOP PROCEDURE MASK (BLUE, YELLOW) | May 28, 1998 | Substantially Equivalent |
| K972883 | ISOSAFE EARLOOP PROCEDURE MASK (BLUE, YELLOW) | Feb 26, 1998 | Substantially Equivalent |
| K952367 | CYPRESS MEDICAL PRODUCTS VINYL EXAMINATION GLOVE | Jul 5, 1995 | Substantially Equivalent |
| K950254 | CYPRESS MEDICAL PRODUCTS STERILE LATEX EXAMINATION GLOVE | Mar 31, 1995 | Substantially Equivalent |
| K950092 | CYPRESS MEDICAL PRODUCTS CATHETER (INSERTION) TRAY | Feb 27, 1995 | Unknown |
| K950109 | CYPRESS MEDICAL PRODUCTS CATHETER (INSERTION) TRAY/WITH OUT CATHETER | Feb 27, 1995 | Unknown |
| K945082 | CYPRESS MEDICAL PRODUCTS STETHOSCOPE | Dec 8, 1994 | Substantially Equivalent |
| K921988 | LACERATION REPAIR TRAY | Nov 19, 1992 | Unknown |