FDA 510(k)
FDA class 1
Substantially Equivalent
🇲🇾 Malaysia
HEALTH-PLUS, SANITEX, RELIANCE (50 MICROGRAMS)
K Number: K993093
·
Decision Oct 29, 1999
Classifications
1
FEI Numbers
151
Registration Numbers
151
Same Product Code
1953
Applicant Total
19
Review Days
43
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Basic Information
- Device Name
- HEALTH-PLUS, SANITEX, RELIANCE (50 MICROGRAMS)
- K Number
- K993093
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6250
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Pamitex Industries Sdn Bhd
- Date Received
- September 16, 1999
- Decision Date
- October 29, 1999
- 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 |
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Other Clearances by Pamitex Industries Sdn Bhd
| K Number | Device Name | ||
|---|---|---|---|
| K003350 | HEALTH-PLUS, SANITEX, RELIANCE MULTIPLY POWDER FREE POLYMER AND NITRILE COATED (BLUE) | Apr 5, 2001 | Substantially Equivalent |
| K001674 | POWDER-FREE LATEX EXAMINATION GLOVES-BLUE COLOR | Jun 30, 2000 | Substantially Equivalent |
| K000952 | HEALTH-PLUS, SANITEX, RELIANCE PRE-POWDERED LATEX EXAMINATION GLOVES - BLUE COLOR | Jun 30, 2000 | Substantially Equivalent |
| K001672 | POWDER-FREE POLYMER-COATED LATEX EXAMINATION GLOVES | Jun 23, 2000 | Substantially Equivalent |
| K993756 | HEALTH-PLUS, SANITEX, RELIANCE STERILE POWDER-FREE NITRILE SURGICAL GLOVES | Apr 28, 2000 | Substantially Equivalent |
| K000828 | HEALTH-PLUS, SANITEX, RELIANCE PRE-POWDERED LAXTEX EXAMINATION GLOVE | Apr 7, 2000 | Substantially Equivalent |
| K993201 | HEALTH-PLUS, SANITEX, RELIANCE POWEDER-FREE STERILE LATEX SURGICAL GLOVES | Mar 29, 2000 | Substantially Equivalent |
| K993918 | HEALTH-PLUS, SANITEX, RELIANCE, POWDER-FREE MULTI-PLY LATEX EXAMINATION GLOVE (NATURAL RUBBER LATEX-NITRILE-CONSTRUCTION | Feb 10, 2000 | Substantially Equivalent |
| K993621 | HEALTH-PLUS, SANITEX, RELIANCE, BLUE PRE-POWDERED LATEX EXAMINATION GLOVES, WITH PROTEIN CONTENT LABELING CLAIM (100 MIC | Dec 29, 1999 | Substantially Equivalent |
| K993097 | HEALTH-PLUS, SANITEX, RELIANCE PRE-POWDERED LATEX EXAMINATINO GLOVES, WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAM | Oct 27, 1999 | Substantially Equivalent |