FDA 510(k)
FDA class 1
Substantially Equivalent
🇲🇾 Malaysia
Brightway Brand Nitrile Examination Gloves, Powder Free (Lavender)
K Number: K162146
·
Decision Jan 5, 2017
Classifications
1
FEI Numbers
380
Registration Numbers
380
Same Product Code
1171
Applicant Total
24
Review Days
157
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Basic Information
- Device Name
- Brightway Brand Nitrile Examination Gloves, Powder Free (Lavender)
- K Number
- K162146
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6250
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Brightway Holdings Sdn. Bhd.
- Date Received
- August 1, 2016
- Decision Date
- January 5, 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)
FDA Class 1
·General Hospital
Other Clearances by Brightway Holdings Sdn. Bhd.
| K Number | Device Name | ||
|---|---|---|---|
| K211816 | Brightway Brand, Nitrile Examination Gloves, Powder Free (Blue) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | Nov 2, 2022 | Substantially Equivalent |
| K170686 | Nitrile Examination Gloves, Powder Free [Purple] Tested for Use with Chemotherapy Drugs | Jul 14, 2017 | Substantially Equivalent |
| K162294 | BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12, POWDER FREE, [PURPLE] TESTED FOR USE WITH CHEMOTHERAPY DRUGS | Apr 21, 2017 | Substantially Equivalent |
| K162186 | BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12, POWDER FREE, [STERLING/GREY] WITH CHEMOTHERAPY CLAIM | Mar 31, 2017 | Substantially Equivalent |
| K163267 | NITRILE EXAMINATION GLOVE | Mar 24, 2017 | Substantially Equivalent |
| K161215 | Brightway Brand Nitrile Examination Gloves, Powder Free, [Sterling/Grey] Tested For Use With Chemotherapy Drugs | Dec 21, 2016 | Substantially Equivalent |
| K102880 | BRIGHTWAY TM BRAND NITRILE EXAMINATION GLOVES, POWDER FREE, NON-STERILE. (GREY COLOR) | Nov 19, 2010 | Substantially Equivalent |
| K060402 | BRIGHTWAY BRAND NITRILE EXAMINATION GLOVE (POWDER FREE, BLACK COLOUR) | Jun 9, 2006 | Substantially Equivalent |
| K060658 | BRIGHTWAY BRAND LATEX EXAMINATION GLOVES (POWDER FREE, BLACK COLOR) | Apr 10, 2006 | Substantially Equivalent |
| K032940 | BRIGHTWAY BRAND LATEX EXAMINATION GLOVE-(POWDER FREE, STERILE) CONTAINING 50 UGM OR LESS OF WATER EXTRACTABLE PROTEIN PE | Nov 20, 2003 | Substantially Equivalent |