FDA 510(k)
FDA class 1
Substantially Equivalent
🇲🇾 Malaysia
TG MEDICAL POWDER-FREE LATEX EXAMINATION GLOVE PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)
K Number: K982872
·
Decision Oct 15, 1998
Classifications
1
FEI Numbers
151
Registration Numbers
151
Same Product Code
1953
Applicant Total
9
Review Days
62
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Basic Information
- Device Name
- TG MEDICAL POWDER-FREE LATEX EXAMINATION GLOVE PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)
- K Number
- K982872
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6250
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Tg Medical Sdn. Bhd.
- Date Received
- August 14, 1998
- Decision Date
- October 15, 1998
- 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 Tg Medical Sdn. Bhd.
| K Number | Device Name | ||
|---|---|---|---|
| K171276 | Sterile Polyisoprene Surgical Powder Free Glove Tested for Use with Chemotherapy Drugs | Aug 21, 2017 | Substantially Equivalent |
| K113393 | POWDER FREE BLACK NITRILE EXAMINATION GLOVES | Sep 11, 2012 | Substantially Equivalent |
| K993562 | POWDER FREE LATEX STERILE SURGICAL GLOVES | Dec 29, 1999 | Substantially Equivalent |
| K992841 | TG MEDICAL POWDERED NITRILE BLUE EXAMINATION GLOVES | Oct 29, 1999 | Substantially Equivalent |
| K992360 | TG MEDICAL POWDERED NITRILE EXAMINATION GLOVES | Oct 12, 1999 | Substantially Equivalent |
| K992219 | POWDERED LATEX STERILE SURGICAL GLOVES | Jul 30, 1999 | Substantially Equivalent |
| K990668 | POWDER FREE BLUE NITRILE GLOVE | Jun 3, 1999 | Substantially Equivalent |
| K941900 | POWDERED LATEX EXAM GLOVES | Jun 21, 1994 | Substantially Equivalent |