FDA 510(k)
FDA class 1
Substantially Equivalent
🇮🇩 Indonesia
Powder Free Polychloroprene Examination Gloves-Pink with Aloe Vera and Vitamin E
K Number: K163041
·
Decision Feb 22, 2017
Classifications
1
FEI Numbers
380
Registration Numbers
380
Same Product Code
1171
Applicant Total
19
Review Days
114
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
- Powder Free Polychloroprene Examination Gloves-Pink with Aloe Vera and Vitamin E
- K Number
- K163041
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6250
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Pt. Medisafe Technologies
- Date Received
- October 31, 2016
- Decision Date
- February 22, 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 |
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 Pt. Medisafe Technologies
| K Number | Device Name | ||
|---|---|---|---|
| K201774 | Polychloroprene Powder Free Sterile Surgical Gloves, Low Dermatitis Potential and Tested for Use with Chemotherapy Drugs | Sep 16, 2020 | Substantially Equivalent |
| K182176 | Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with Chemotherapy Drugs | Mar 28, 2019 | Substantially Equivalent |
| K173258 | Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with Chemotherapy | Apr 20, 2018 | Substantially Equivalent |
| K142941 | Powder-Free Polyisoprene Sterile Surgical Gloves in White Color Tested for Use with Chemotherapy Drugs, Powder-Free Polyisoprene Sterile Surgical Gloves in Green Color. | Nov 2, 2015 | Substantially Equivalent |
| K142190 | Polychloroprene Powder-free Surgical Glove (White) Tested for Use with Chemotherapy Drugs; Polychloroprene Powder-free Surgical Glove (Green) Tested for Use with Chemotherapy Drugs | Jul 14, 2015 | Substantially Equivalent |
| K133689 | POWDER FREE POLYCHLOROPRENE LIGHT WIEGHT EXAMINATIONGLOVES- GREEN,BLUE AND PINK | Jul 3, 2014 | Substantially Equivalent |
| K112654 | POWDERFREE POLYISOPRENE SURGICAL GLOVES | Feb 17, 2012 | Substantially Equivalent |
| K102623 | BLUE POWDERFREE NITRILE EXAMINATION GLOVE | Jun 6, 2011 | Substantially Equivalent |
| K102620 | POWDERFREE BLACK NITRILE EXAMINATION GLOVES | Nov 22, 2010 | Substantially Equivalent |
| K082302 | POWDER FREE NITRILE PATIENT EXAMINATION GLOVES WITH CHEMO LABELING CLAIM | Dec 9, 2008 | Substantially Equivalent |