FDA 510(k)
FDA class 1
Substantially Equivalent
🇲🇾 Malaysia
Powder-Free Polychloroprene Examination Glove (Green Color) Tested for Use with Chemotherapy Drugs and Fentanyl
K Number: K250342
·
Decision Jul 8, 2025
Classifications
1
FEI Numbers
444
Registration Numbers
445
Same Product Code
1158
Applicant Total
3
Review Days
152
Basic Information
- Device Name
- Powder-Free Polychloroprene Examination Glove (Green Color) Tested for Use with Chemotherapy Drugs and Fentanyl
- K Number
- K250342
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6250
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Encompass Industries Sdn. Bhd.
- Date Received
- February 6, 2025
- Decision Date
- July 8, 2025
- 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 Encompass Industries Sdn. Bhd.
| K Number | Device Name | ||
|---|---|---|---|
| K220609 | Powder-Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl (White, Blue, Black, Orange and Green Color) | May 27, 2022 | Substantially Equivalent |
| K183562 | Powder-Free Nitrile Examination Glove (White Colored, Blue Colored, and Black Colored) Tested for Use with Chemotherapy Drugs | Oct 23, 2019 | Substantially Equivalent |