FDA 510(k)
FDA class 1
Substantially Equivalent
🇲🇾 Malaysia
POWDER FREE BLACK NITRILE EXAMINATION GLOVES
K Number: K113393
·
Decision Sep 11, 2012
Classifications
1
FEI Numbers
380
Registration Numbers
380
Same Product Code
1171
Applicant Total
9
Review Days
299
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Basic Information
- Device Name
- POWDER FREE BLACK NITRILE EXAMINATION GLOVES
- K Number
- K113393
- 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
- November 17, 2011
- Decision Date
- September 11, 2012
- Product Code
- LZA
- 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 |
|---|---|---|---|
| LZA | Polymer Patient Examination Glove | FDA class 1 | General Hospital |
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Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Xylazine HCl, and Simulated Gastric Acid; Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Blue), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Xylazine HCl, and Simulated Gastric Acid
FDA 510(k)
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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 |
| 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 |
| K982872 | TG MEDICAL POWDER-FREE LATEX EXAMINATION GLOVE PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) | Oct 15, 1998 | Substantially Equivalent |
| K941900 | POWDERED LATEX EXAM GLOVES | Jun 21, 1994 | Substantially Equivalent |