FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
NON-STERILE, POWDER-FREE, GREEN LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
K Number: K112005
·
Decision Mar 21, 2012
Classifications
1
FEI Numbers
151
Registration Numbers
151
Same Product Code
1953
Applicant Total
3
Review Days
252
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
- NON-STERILE, POWDER-FREE, GREEN LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
- K Number
- K112005
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6250
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ug Healthcare (Usa), Inc.
- Date Received
- July 13, 2011
- Decision Date
- March 21, 2012
- 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