Data / Medical devices / Thailand / Emerald Nonwovens Intl. Co., Ltd.
Emerald Nonwovens Intl. Co., Ltd.: FDA-registered device maker in Phetchaburi, Thailand, 2 510(k) clearances
Emerald Nonwovens Intl. Co., Ltd. is registered with the FDA (registration 3003495693) in Phetchaburi, Thailand. It lists 20 device types. The FDA files 2 510(k) clearances under its listings, the newest dated March 8, 2005. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3003495693
- Address
- 88, 88/1 Moo 2, Nong Chumpon Nean Kao-Yoi, Phetchaburi, Thailand, 76140
- Owner or operator
- EMERALD NONWOVENS INTL. CO., LTD. (9047422)
- Roles
- Contract manufacturer, Contract sterilizer, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- August 24, 2001
- Registered through
- 2026
- Brand names listed
- BEDPADS, BOUFFANT CAP, Chemo Surgical Gown, DISPOSABLE PATIENT ISOLATION GOWN, Face Mask, Gemini Sterilization Wrap, SHEETS, UNDERPADS
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessory, Surgical Apparel | LYU | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Bandage, Elastic | FQM | 1 | Contract manufacturer | accessdata.fda.gov |
| Bedding, Disposable, Medical | KME | 1 | Contract manufacturer, Manufacturer, Specification developer | accessdata.fda.gov |
| Cap, Surgical | FYF | 1 | Contract manufacturer, Manufacturer, Specification developer | accessdata.fda.gov |
| Cover, Barrier, Protective | MMP | 2 | Contract manufacturer | accessdata.fda.gov |
| Cover, Shoe, Operating-Room | FXP | 1 | Contract manufacturer, Manufacturer, Specification developer | accessdata.fda.gov |
| Drape, Surgical, Antimicrobial | KKX | 2 | Contract manufacturer, Contract sterilizer, Repackager or relabeler | accessdata.fda.gov |
| Drape, Surgical, Exempt | PUI | 2 | Contract manufacturer, Contract sterilizer, Repackager or relabeler | accessdata.fda.gov |
| Fiber, Medical, Absorbent | FRL | 1 | Contract manufacturer | accessdata.fda.gov |
| General Surgery Tray | LRO | 2 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Gown, Examination | FME | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Gown, Isolation, Surgical | FYC | 2 | Contract manufacturer | accessdata.fda.gov |
| Gown, Surgical | FYA | 2 | Contract manufacturer, Contract sterilizer, Repackager or relabeler | accessdata.fda.gov |
| Instrument, Manual, Surgical, General Use | MDM | 1 | Contract manufacturer | accessdata.fda.gov |
| Mask, Surgical | FXX | 2 | Contract manufacturer | accessdata.fda.gov |
| Non-Surgical Gown | OEA | 1 | Contract manufacturer | accessdata.fda.gov |
| Restraint, Protective | FMQ | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Support, Patient Position | CCX | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Tray, Surgical, Instrument | FSM | 1 | Contract manufacturer, Contract sterilizer, Repackager or relabeler | accessdata.fda.gov |
| Wrap, Sterilization | FRG | 2 | Contract 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 |
|---|---|---|---|---|---|---|
| March 8, 2005 | K043017 | PREVENTION BREATHABLE, IMPERVIOUS SURGICAL GOWNS | FYA | Substantially Equivalent | Medline Industries, Inc. | accessdata.fda.gov |
| February 25, 1997 | K964142 | MEDLINE DISPOSABLE SURGICAL DRAPES AND GOWNS | KKX | Substantially Equivalent | Medline Industries, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Gown, Surgical
- All makers of Cap, Surgical
- All makers of Wrap, Sterilization
- All makers of Cover, Barrier, Protective
- All makers of Cover, Shoe, Operating-Room
- All makers of Bandage, Elastic
Updated March 8, 2005. 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.