Data / Medical devices / United States / CWGC La Inc
CWGC La Inc: FDA-registered device maker in Chino, CA, United States, 5 510(k) clearances
CWGC La Inc is registered with the FDA (registration 3009549523) in Chino, CA, United States. It lists 7 device types. The FDA files 5 510(k) clearances under its listings, the newest dated May 10, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009549523
- Address
- 12425 Mills Ave Ste A4, Chino, CA, United States, 91710
- Owner or operator
- CWGC LA INC (10040422)
- Roles
- Complaint file establishment, Repackager or relabeler
- First device listed
- February 24, 2017
- Registered through
- 2026
- Brand names listed
- 2.5g PURPLE EXAM NITRILE GLOVES, Extra Large, 100/box, 10 boxes/cs, 2.5g PURPLE EXAM NITRILE GLOVES, Large, 100/box, 10 boxes/cs, 2.5g PURPLE EXAM NITRILE GLOVES, Medium, 100/box, 10 boxes/cs, 2.5g PURPLE EXAM NITRILE GLOVES, Small, 100/box, 10 boxes/cs, 3.5g BLUE EXAM NITRILE GLOVES, Extra Large, 100/box, 10 boxes/cs, 3.5g BLUE EXAM NITRILE GLOVES, Large, 100/box, 10 boxes/cs, 3.5g BLUE EXAM NITRILE GLOVES, Medium, 100/box, 10 boxes/cs, 3.5g BLUE EXAM NITRILE GLOVES, Small, 100/box, 10 boxes/cs and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessory, Surgical Apparel | LYU | 1 | Repackager or relabeler | accessdata.fda.gov |
| Cup, Prophylaxis | EHK | 1 | Repackager or relabeler | accessdata.fda.gov |
| Pad, Menstrual, Scented, Scented-Deodorized Made Of Common Cellulosic & Synthetic Material W/Established Safety Profile | NRC | 1 | Repackager or relabeler | accessdata.fda.gov |
| Pad, Menstrual, Unscented | HHD | 1 | Repackager or relabeler | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Respirator, Surgical | MSH | 2 | Repackager or relabeler | accessdata.fda.gov |
| Vinyl Patient Examination Glove | LYZ | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 10, 2019 | K182612 | Powder Free Nitrile Examination Gloves (Cobalt Blue, Black, Blue and Violet Blue) | LZA | Substantially Equivalent | Zibo Yahao Supplies Co., Ltd. | accessdata.fda.gov |
| May 10, 2018 | K172867 | Nitrile Examination Powder Free Glove, Black, Nitrile Examination Powder Free Glove, Orange | LZA | Substantially Equivalent | Gmp Medicare Sdn Bhd (F25) | accessdata.fda.gov |
| September 21, 2011 | K111857 | SYNTHETIC VINYL EXAMINATION GLOVE POWDER FREE | LYZ | Substantially Equivalent | Inmed Gloves Factory | accessdata.fda.gov |
| July 6, 2011 | K111012 | SYNTHETIC VINYL EXAMINATION GLOVES, POWDER FREE (BLUE/GREEN) (AND MULTIPLE LABELS) | LYZ | Substantially Equivalent | True Glove Factory | accessdata.fda.gov |
| February 9, 2001 | K003985 | POWDERFREE NITRILE PATIENT EXMINATION GLOVE | LZA | Substantially Equivalent | Guthrie Medicare Products (Melaka) Sdn Bhd | accessdata.fda.gov |
Compare with other makers
- All makers of Vinyl Patient Examination Glove
- All makers of Polymer Patient Examination Glove
- All makers of Pad, Menstrual, Unscented
- All makers of Pad, Menstrual, Scented, Scented-Deodorized Made Of Common Cellulosic & Synthetic Material W/Established Safety Profile
- All makers of Accessory, Surgical Apparel
- All makers of Cup, Prophylaxis
Updated May 10, 2019. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.