Data / Medical devices / United States / New York Embroidery Studio
New York Embroidery Studio: FDA-registered device maker in Brooklyn, NY, United States, 1 510(k) clearance
New York Embroidery Studio is registered with the FDA (registration 3007088677) in Brooklyn, NY, United States. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated May 13, 2021. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007088677
- Address
- 140 58th St. Building A, Suite 8N, Brooklyn, NY, United States, 11220
- Owner or operator
- NEW YORK EMBROIDERY STUDIO (10073842)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- May 14, 2020
- Registered through
- 2026
- Brand names listed
- Non-Reinforced Surgical Gown, L4, Non-Surgical Gown - E52 Isolation Gown, Poly-Reinforced Surgical Gown, L4, SafeSource Direct Procedure Mask with Ear Loops - Level 1, SafeSource Direct Procedure Mask with Ear Loops - Level 3, SafeSource Direct Surgical Mask with Ties - Level 1, SafeSource Direct Surgical Mask with Ties - Level 3, Standard Surgical Gown and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Gown, Surgical | FYA | 2 | Contract manufacturer | accessdata.fda.gov |
| Mask, Surgical | FXX | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Non-Surgical Gown | OEA | 1 | Manufacturer | 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 13, 2021 | K202697 | United Sewing High Fluid Resistant Disposable Face Mask, United Sewing High Fluid Resistant Surgical Mask, United Sewing High Fluid Resistant Procedure Mask | FXX | Substantially Equivalent | United Sewing Automation, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| July 31, 2026 | 99760 | Class II | Ongoing | New York Embroidery Studio Trinity Non-Surgical Isolation Gown, AAMI PB70 Level 2, X-Large. Model Number: NYES100-2. Packaged in inner packs of 10 and 100 gowns per shipping case. | Gowns do not consistently meet the minimum liquid-barrier performance required. | accessdata.fda.gov |
Compare with other makers
Updated September 23, 2026. 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.