FDA 510(k)
FDA class 1
Substantially Equivalent
🇮🇩 Indonesia
Powder Free Nitrile Examination Gloves, Black
K Number: K161099
·
Decision Feb 23, 2017
Classifications
1
FEI Numbers
380
Registration Numbers
380
Same Product Code
1171
Applicant Total
11
Review Days
310
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Basic Information
- Device Name
- Powder Free Nitrile Examination Gloves, Black
- K Number
- K161099
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6250
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Pt. Maja Agung Latexindo
- Date Received
- April 19, 2016
- Decision Date
- February 23, 2017
- 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 Pt. Maja Agung Latexindo
| K Number | Device Name | ||
|---|---|---|---|
| K212408 | Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs Use and Simulated Gastric Acid) | May 18, 2022 | Substantially Equivalent |
| K081488 | POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE | Aug 28, 2008 | Substantially Equivalent |
| K062709 | POWDER FREE LATEX EXAMINATION GLOVES, BLACK | Dec 6, 2006 | Substantially Equivalent |
| K020040 | LATEX PRE-POWDERED EXAMINATION GLOVES WITH PROTEIN CLAIM | Aug 1, 2002 | Substantially Equivalent |
| K013996 | LATEX POWDERFREE STERILE EXAMINATION GLOVES, MODELS-EXTRA SMALL, SMALL, MEDIUM, LARGE, EXTRA LARGE | Feb 26, 2002 | Substantially Equivalent |
| K001274 | LATEX SURGEON SURGEON'S GLOVES POWDER-FREE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) | Jun 23, 2000 | Substantially Equivalent |
| K994255 | LATEX EXAMINATION GLOVES-PRE-POWDERED-STERILE | Feb 7, 2000 | Substantially Equivalent |
| K992752 | SURGEON'S GLOVES PRE-POWDERED, MODELS 6.5, 7, 7.5, 8, 8.5 | Nov 5, 1999 | Substantially Equivalent |
| K982897 | POWDER FREE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) | Dec 23, 1998 | Substantially Equivalent |
| K896604 | MAL LATEX EXAMINATION GLOVES | Jan 2, 1990 | Substantially Equivalent |