Data / Medical devices / China / Encompass Medical Supplies, Inc Limited
Encompass Medical Supplies, Inc Limited: FDA-registered device maker in Pudong New Area Shanghai, China, 4 510(k) clearances
Encompass Medical Supplies, Inc Limited is registered with the FDA (registration 3005885230) in Pudong New Area Shanghai, China. It lists 1 device type. The FDA files 4 510(k) clearances under its listings, the newest dated May 2, 2012. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3005885230
- Address
- Block 13 No.300, Shuang Qiao Road Pudong New Area, Pudong New Area Shanghai, China, 201208
- Owner or operator
- Encompass Medical Supplies, Inc Limited (10058038)
- Roles
- Exporter to the US
- First device listed
- June 27, 2018
- Registered through
- 2026
- Brand names listed
- Aura, Bosma, High Five, IDEAL, Ideal, MICROFLEX COBALT, MICROFLEX INTEGRA EC, Nu Glove and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Polymer Patient Examination Glove | LZA | 1 | Exporter to the US | 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 2, 2012 | K120184 | POWDER FREE NITRILE EXAMINATION GLOVE, BLUE COLORED, BLACK COLORED AND WHITE COLORED | LZA | Substantially Equivalent | Encompass Medical Supplies Inc Limited | accessdata.fda.gov |
| April 28, 2006 | K060147 | POWDER FREE NITRILE EXAMINATION GLOVES, BLUE | LZA | Substantially Equivalent | Hongye Plastic Products Co., Ltd. | accessdata.fda.gov |
| September 30, 2004 | K042226 | SYNTEX POWDER-FREE NITRILE EXAMINATION GLOVE, TESTED FOR CHEMOTHERAPY | LZA | Substantially Equivalent | Syntex Healthcare Products Co., Ltd. | accessdata.fda.gov |
| February 26, 2002 | K020493 | SYNTEX POWDER-FREE NITRILE EXAMINATION GLOVE | LZA | Substantially Equivalent | Syntex Healthcare Products Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated May 2, 2012. 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.