FDA 510(k)
FDA class 1
Substantially Equivalent
🇮🇩 Indonesia
POWDERFREE POLYCHLOROPRENE STERILE EXAMINATION GLOVES
K Number: K050968
·
Decision Jul 12, 2005
Classifications
1
FEI Numbers
380
Registration Numbers
380
Same Product Code
1171
Applicant Total
19
Review Days
85
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Basic Information
- Device Name
- POWDERFREE POLYCHLOROPRENE STERILE EXAMINATION GLOVES
- K Number
- K050968
- 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
- April 18, 2005
- Decision Date
- July 12, 2005
- 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 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 |
| K163041 | Powder Free Polychloroprene Examination Gloves-Pink with Aloe Vera and Vitamin E | Feb 22, 2017 | 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 |