FDA 510(k)
FDA class 1
Substantially Equivalent
🇲🇾 Malaysia
White Nitrile Examination Glove, Sterile with Chemotherapy Drugs Claim
K Number: K180452
·
Decision Jun 12, 2018
Classifications
1
FEI Numbers
380
Registration Numbers
380
Same Product Code
1171
Applicant Total
15
Review Days
112
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Basic Information
- Device Name
- White Nitrile Examination Glove, Sterile with Chemotherapy Drugs Claim
- K Number
- K180452
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6250
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Riverstone Resources Sdn Bhd
- Date Received
- February 20, 2018
- Decision Date
- June 12, 2018
- 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 Riverstone Resources Sdn Bhd
| K Number | Device Name | ||
|---|---|---|---|
| K220672 | Blue Powder Free Nitrile Examination Glove with Grape Scented, Chemotherapy Drugs and Fentanyl Test Claim | Jun 3, 2022 | Substantially Equivalent |
| K220401 | Pink Powder Free Nitrile Examination Glove With Bubblegum Scented, Chemotherapy Drugs And Fentanyl Test Claim | Apr 9, 2022 | Substantially Equivalent |
| K200326 | Powder Free Nitrile Examination Glove (Aqua Green) | Apr 9, 2020 | Substantially Equivalent |
| K190725 | Nitrile Examination Glove Sterile Tested for use with Chemotherapy Drugs Claim, White | Dec 17, 2019 | Substantially Equivalent |
| K152542 | Powder Free Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with tested for Use with Chemotherapy Drugs | Dec 24, 2015 | Substantially Equivalent |
| K133193 | RS ORANGE NITRILE MEDICAL EXAMINATION GLOVES (POWDER FREE) | Jun 23, 2014 | Substantially Equivalent |
| K112924 | RS SAFE BLACK NITRILE MEDICAL EXAMINATION GLOVES POWDER OR OTHER PROPRIETARY NAME | May 2, 2012 | Substantially Equivalent |
| K112928 | RS SAFE WHITE NITRILE MEDICAL EXAMINATION GLOVES POWDER FREE OR OTHER PROPRIETARY NAME | Apr 17, 2012 | Substantially Equivalent |
| K100603 | RS SAFE BLUE NITRILE MEDICAL EXAMINATION GLOVES (POWDER FREE) | Jul 16, 2010 | Substantially Equivalent |
| K100611 | RS CARE LATEX MEDICAL EXAMINATION GLOVE (POWDER FREE) | Jul 16, 2010 | Substantially Equivalent |