FDA 510(k)
FDA class 1
Substantially Equivalent
🇲🇾 Malaysia
MEDI-PLUS, HEALTH-PLUS, SANITEX, RELIANCE
K Number: K973913
·
Decision Dec 18, 1997
Classifications
1
FEI Numbers
151
Registration Numbers
151
Same Product Code
1953
Applicant Total
11
Review Days
65
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
- MEDI-PLUS, HEALTH-PLUS, SANITEX, RELIANCE
- K Number
- K973913
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6250
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Pwa Industries Sdn. Bhd.
- Date Received
- October 14, 1997
- Decision Date
- December 18, 1997
- 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 Pwa Industries Sdn. Bhd.
| K Number | Device Name | ||
|---|---|---|---|
| K011895 | POWDER-FREE MULTI-PLY LATEX EXAMINATION GLOVES, POLYMER COATED ON OUTSIDE AND NITRILE COATED ON INSIDE, BLUE COLOR WITH | Jul 9, 2001 | Substantially Equivalent |
| K010077 | HEALTH-PLUS, SANITEX, RELIANCE POWDER-FREE NITRILE EXAMINATION GLOVES | Feb 28, 2001 | Substantially Equivalent |
| K001485 | HEALTH-PLUS, SANITEX, RELIANCE, POWDER-FREE LATEX EXAMINATION GLOVES | Jun 13, 2000 | Substantially Equivalent |
| K001475 | HEALTH-PLUS, SANITEX, RELIANCE, POWDERED LATEX EXAM GLOVES CONTAINS 100 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PR | Jun 13, 2000 | Substantially Equivalent |
| K981774 | MEDI-PLUS, HEALTH-PLUS, SANITEX, RELIANCE | Jul 24, 1998 | Substantially Equivalent |
| K973551 | MEDI-PLUS, HEALTH-PLUS, SANITEX, RELIANCE | Nov 6, 1997 | Substantially Equivalent |
| K972169 | MEDI-PLUS, HEALTH-PLUS, SANITEX, RELIANCE | Oct 3, 1997 | Substantially Equivalent |
| K964724 | POWDER-FREE LATEX EXAMINATION GLOVES | Jun 16, 1997 | Substantially Equivalent |
| K963560 | MEDI-PLUS, HEALTH-PLUS, SANITEX, RELIANCE | Oct 24, 1996 | Substantially Equivalent |
| K953138 | MEDI-PLUS, HEALTH PLUS, SANITEX, RELIANCE | Sep 22, 1995 | Substantially Equivalent |