FDA 510(k)
FDA class 1
Substantially Equivalent
🇲🇾 Malaysia
Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs and Fentanyl Citrate
K Number: K221626
·
Decision Dec 7, 2022
Classifications
1
FEI Numbers
380
Registration Numbers
380
Same Product Code
1171
Applicant Total
10
Review Days
184
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Basic Information
- Device Name
- Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs and Fentanyl Citrate
- K Number
- K221626
- Device Class
- FDA class 1
- Clearance Type
- Abbreviated
- Regulation Number
- 880.6250
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Jr Engineering & Medical Technologies (M) Sdn. Bhd.
- Date Received
- June 6, 2022
- Decision Date
- December 7, 2022
- 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 Jr Engineering & Medical Technologies (M) Sdn. Bhd.
| K Number | Device Name | ||
|---|---|---|---|
| K222350 | Sterile Nitrile Surgical Gloves Powder Free | Apr 13, 2023 | Substantially Equivalent |
| K222348 | JR MEDIC | Oct 27, 2022 | Substantially Equivalent |
| K221169 | JR MEDIC Nitrile Examination Gloves Powder Free- Black | Oct 25, 2022 | Substantially Equivalent |
| K222349 | JR MEDIC Nitrile Examination Gloves Powder Free (Orange, Purple) | Oct 21, 2022 | Substantially Equivalent |
| K221157 | JR Medic | Aug 30, 2022 | Substantially Equivalent |
| K212827 | Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs | Dec 6, 2021 | Substantially Equivalent |
| K192328 | JR.MEDIK Latex Surgeons Gloves Powder Free | Mar 10, 2020 | Substantially Equivalent |
| K192333 | Blue Nitrile Examination Gloves Powder Free | Jan 24, 2020 | Substantially Equivalent |
| K192329 | Blue Latex Examination Powder Free Gloves | Nov 25, 2019 | Substantially Equivalent |