FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
STERILE PATIENT EXAMINATION GLOVES
K Number: K903756
·
Decision Sep 5, 1990
Classifications
1
FEI Numbers
151
Registration Numbers
151
Same Product Code
1953
Applicant Total
6
Review Days
23
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 PATIENT EXAMINATION GLOVES
- K Number
- K903756
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6250
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Tillotson Rubber Co., Inc.
- Date Received
- August 13, 1990
- Decision Date
- September 5, 1990
- 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
Other 510(k) clearances with the same product code (LYY), ordered by most recent decision date.
Powder Free Natural Rubber Latex Examination Gloves Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less Protein
FDA 510(k)
FDA Class 1
·General Hospital
Latex Examination Glove Powder Free (Ocean Blue and Natural White)
FDA 510(k)
FDA Class 1
·General Hospital
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)
FDA 510(k)
FDA Class 1
·General Hospital
Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L)
FDA 510(k)
FDA Class 1
·General Hospital
Powder-Free Latex examination gloves
FDA 510(k)
FDA Class 1
·General Hospital
Non Sterile Powder Free Latex Examination Glove
FDA 510(k)
FDA Class 1
·General Hospital
Other Clearances by Tillotson Rubber Co., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K905765 | PILGRIM NITRILE LATEX GLOVES (VARIOUS TYPES) | Feb 25, 1991 | Substantially Equivalent |
| K903607 | POWDER FREE, NON-STERILE EXAMINATION GLOVES | Aug 17, 1990 | Substantially Equivalent |
| K894828 | HPI ORTHO SURGEONS' GLOVE | May 7, 1990 | Substantially Equivalent |
| K780181 | GLOVES, FLOOR | Feb 21, 1978 | Substantially Equivalent |
| K770704 | GLOVES, SURGEONS, LATEX | Jun 24, 1977 | Substantially Equivalent |