FDA 510(k)
FDA class 1
Substantially Equivalent
🇲🇾 Malaysia
Violet Nitrile Powder Free Patient Examination Glove, Non Sterile
K Number: K210587
·
Decision Jun 28, 2021
Classifications
1
FEI Numbers
380
Registration Numbers
380
Same Product Code
1171
Applicant Total
7
Review Days
122
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Basic Information
- Device Name
- Violet Nitrile Powder Free Patient Examination Glove, Non Sterile
- K Number
- K210587
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6250
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Onetexx Sdn Bhd
- Date Received
- February 26, 2021
- Decision Date
- June 28, 2021
- 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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Other Clearances by Onetexx Sdn Bhd
| K Number | Device Name | ||
|---|---|---|---|
| K222298 | Violet Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested for Use With Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl In Gastric Acid | Oct 18, 2022 | Substantially Equivalent |
| K222294 | Black Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested for Use With Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl In Gastric Acid | Sep 24, 2022 | Substantially Equivalent |
| K221773 | Blue Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested For Use With the Opioid Fentanyl Citrate, Simulated Gastric Acid, and Fentanyl In Gastric Acid | Jul 30, 2022 | Substantially Equivalent |
| K210588 | Black Nitrile Powder Free Patient Examination Glove, Non Sterile | Oct 31, 2021 | Substantially Equivalent |
| K210775 | White Nitrile Powder Free Patient Examination Glove, Non Sterile | Jun 28, 2021 | Substantially Equivalent |
| K210366 | Blue Nitrile Powder Free Patient Examination Glove, Non Sterile | May 7, 2021 | Substantially Equivalent |