Encompass Medical Supplies, Inc Limited
Manufacturer and brand owner in Pudong New Area, Shanghai, China. 1 device type, 1 product catalogued, 1 clearance.
Encompass Medical Supplies, Inc Limited is an exporter holding a current FDA establishment registration. The registration covers Polymer Patient Examination Glove. 1 of its products is catalogued under its own name. Its earliest product listing with the FDA dates from 2018.
Registration
| Registered name | ENCOMPASS MEDICAL SUPPLIES, INC LIMITED |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3005885230 |
| FEI number | 3005885230 |
| DUNS | 120958546 |
| Establishment type | Exporter |
Location
| City | Pudong New Area |
|---|---|
| Province | Shanghai |
| Address | Block 13 No.300, Shuang Qiao Road |
| Postal code | 201208 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Polymer Patient Examination Glove | Class 1 | Radnor, Zircon Blue, Aura, Microflex Integra EC, Ideal, High Five and 4 more | 2018 | 83 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Powder Free Nitrile Examination Gloves,Non Sterile Blue Colored | LZA | 3 |
Clearances
1 clearance names Encompass Medical Supplies, Inc Limited as applicant. 3 are held by other companies and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K120184 | 2012-05-02 | LZA | Traditional | This company |
| K060147 | 2006-04-28 | LZA | Traditional | Hongye Plastic Products Co., Ltd. |
| K042226 | 2004-09-30 | LZA | Traditional | Syntex Healthcare Products Co., Ltd. |
| K020493 | 2002-02-26 | LZA | Traditional | Syntex Healthcare Products Co., Ltd. |
From the Company
Published by the company on its own website, not by the FDA.
| Main products | Medical supplies, Disposable gloves |
|---|---|
| Export markets | Medical, dental, laboratory, food processing, sanitation |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.