FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
Microflex Nitrile Patient Examination Gloves with Aloe and Chamomile Blue Green Pink Colored Tested for
K Number: K200671
·
Decision Jun 19, 2020
Classifications
1
FEI Numbers
380
Registration Numbers
380
Same Product Code
1171
Applicant Total
26
Review Days
98
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Microflex Nitrile Patient Examination Gloves with Aloe and Chamomile Blue Green Pink Colored Tested for
- K Number
- K200671
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6250
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ansell Healthcare Products, LLC
- Date Received
- March 13, 2020
- Decision Date
- June 19, 2020
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LZA), ordered by most recent decision date.
Powder Free Nitrile Examination Gloves Non-Sterile Black
FDA 510(k)
FDA Class 1
·General Hospital
Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue); Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black)
FDA 510(k)
FDA Class 1
·General Hospital
Nitrile Disposable Examination Gloves
FDA 510(k)
FDA Class 1
·General Hospital
Powder Free Blue Nitrile Examination Glove - Tested for Use with Chemotherapy Drugs and Fentanyl;Powder Free Black Nitrile Examination Glove - Tested for Use with Chemotherapy Drugs and Fentanyl
FDA 510(k)
FDA Class 1
·General Hospital
Syntex Exam Gloves
FDA 510(k)
FDA Class 1
·General Hospital
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 Ansell Healthcare Products, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K230079 | Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs and Low Dermatitis Potential | Aug 23, 2023 | Substantially Equivalent |
| K213289 | Gammex® PI Plus Glove-in-Glove System Tested For Use with Chemotherapy Drugs | May 26, 2023 | Substantially Equivalent |
| K212148 | Non-Sterile Powder-Free Polychloroprene Examination Glove (Blue) Tested for Use with Chemotherapy Drugs | Mar 10, 2022 | Substantially Equivalent |
| K210401 | Microflex Nitrile Patient Examination Gloves Blue Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, Microflex Nitrile Patient Examination Gloves Green Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, Microflex Nitrile Patient Examination Gloves Black Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | Jun 13, 2021 | Substantially Equivalent |
| K190018 | Gammex Non Latex PI White Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs | May 23, 2019 | Substantially Equivalent |
| K182948 | Gammex PI Hybrid Surgical Gloves Tested for Use with Chemotherapy Drugs | Mar 22, 2019 | Substantially Equivalent |
| K171375 | Gammex PI Breach Detect Powder Free Surgical Glove | Feb 6, 2018 | Substantially Equivalent |
| K171737 | Micro Touch Denta Glove Nitrile Hydrasoft Patient Examination Gloves | Dec 29, 2017 | Substantially Equivalent |
| K171172 | Skyn Original Polyisoprene Lubricated Male Condom - Flavored | Aug 2, 2017 | Substantially Equivalent |
| K163107 | Lifestyles Zero Lubricated Latex Male Condom | Jan 23, 2017 | Substantially Equivalent |