FDA 510(k)
FDA class 1
Substantially Equivalent
🇲🇾 Malaysia
Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs Aqua Blue (ABLU), Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs Violet Blue (VBLU) - Extended Cuff
K Number: K180786
·
Decision Nov 2, 2018
Classifications
1
FEI Numbers
380
Registration Numbers
380
Same Product Code
1171
Applicant Total
61
Review Days
221
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Basic Information
- Device Name
- Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs Aqua Blue (ABLU), Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs Violet Blue (VBLU) - Extended Cuff
- K Number
- K180786
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6250
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Hartalega Sdn Bhd
- Date Received
- March 26, 2018
- Decision Date
- November 2, 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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FDA 510(k)
FDA Class 1
·General Hospital
Other Clearances by Hartalega Sdn Bhd
| K Number | Device Name | ||
|---|---|---|---|
| K201748 | Latex Powder Free Surgical Glove with Protein Labelling Claim of 50 Microgram or Less per Gram of Glove and Tested for use with Chemotherapy Drugs | Oct 2, 2020 | Substantially Equivalent |
| K201531 | Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) | Aug 5, 2020 | Substantially Equivalent |
| K200897 | Polyisoprene Powder Free Surgical Underglove for Use with Chemotherapy Drugs (Blue), Polyisoprene Powder Free Surgical Glove for Use with Chemotherapy Drugs (Natural) | Jun 1, 2020 | Substantially Equivalent |
| K180645 | Powder Free Examination Gloves with Colloidal Oatmeal USP and Tested for Use with Chemotherapy Drugs - (Lemon Green) | Nov 16, 2018 | Substantially Equivalent |
| K173509 | Biodegradable Nitrile Powder Free Examination Glove (Blue) | Aug 17, 2018 | Substantially Equivalent |
| K180644 | Nitrile Powder Free Examination Gloves with Colloidal Oatmeal - Lemon Green | Aug 10, 2018 | Substantially Equivalent |
| K180505 | Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP with Low-Dermatitis Potential Claim and Tested For Use with Chemotherapy Drugs (White) | Jun 14, 2018 | Substantially Equivalent |
| K173137 | Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Pink) | Dec 12, 2017 | Substantially Equivalent |
| K171874 | Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant and Tested for Use With Chemotherapy Drugs (Dawn Blue) | Oct 12, 2017 | Substantially Equivalent |
| K170152 | POLYCHLOROPRENE POWDER FREE SURGICAL GLOVE (GREEN) | May 5, 2017 | Substantially Equivalent |