SW Technologies Inc.
Registration 2939388FEI 2939388UNION CITY, CA
Owner/operator: SW TECHNOLOGIES INC.
- Develop Specifications But Do Not Manufacture At This Facility
- Manufacture Medical Device
- Remanufacture Medical Device
- Repack or Relabel Medical Device
- Reprocess Single-Use Device
Renewal due by December 31, 2026
Registered through 2026. Renew between October 1 and December 31, 2026, to stay registered for 2027.
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The 2026 window
- Oct 1Window opens91 days left
- Nov 3Where you stand58 days left
- Dec 1Our pay-by date30 days left
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- FDA fee, FY2027
- $13,785
- Our pay-by suggestion
- Dec 1
- Listed devices
- 37
- Added, last 12 months
- 4
FDA sets who pays the fee and who may qualify for a waiver; its fee page says so. The fee is paid only on FDA’s own fee site. Never through us. FDA’s fee page
The steps, in order
Pay FDA's annual feeYou
Order and pay the FY2027 establishment fee on FDA's Device Facility User Fee site. FDA emails you a PIN when you order.
FDA: registration and listing payment processWait for the payment confirmation numberYou
FDA emails a Payment Confirmation Number (PCN) once the payment processes, which FDA says typically takes several days. That is why we suggest paying by December 1.
FDA: registration and listing payment processRenew the registration in FDA's systemYou
Sign in to FDA's Unified Registration and Listing System (FURLS), complete the annual registration and apply your PIN and PCN. FDA does not count the registration as complete until both are applied.
FDA: device registration and listingReview every listingYou
In the same window, review each listing on file and report any changes, deletions and new listings. Your Listing Review Sheet puts every listing on one page.
FDA: device registration and listing
Every listed device 37
| Code | Device | Class | Regulation | Premarket |
|---|---|---|---|---|
| QDO | Fentanyl And Other Opioid Protection GloveGeneral HospitalAdded Aug 26, 2026 | Class 1 | 21 CFR 880.6250 | K252117 |
| LYY | TEXTURED POWDER-FREE LATEX EXAMINATION GLOVES CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAMLatex Patient Examination Glove | Class 1 | 21 CFR 880.6250 | K011045 |
| LYY | POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIMS GREEN COLORLatex Patient Examination Glove | Class 1 | 21 CFR 880.6250 | K022220 |
| LYY | Hydrex Nitrile Exam GlovesLatex Patient Examination Glove | Class 1 | 21 CFR 880.6250 | K061756 |
| LYY | LATEX GLOVESLatex Patient Examination Glove | Class 1 | 21 CFR 880.6250 | K013795 |
| LYY | Latex GlovesLatex Patient Examination Glove | Class 1 | 21 CFR 880.6250 | K011044 |
| LYY | LATEX GLOVESLatex Patient Examination Glove | Class 1 | 21 CFR 880.6250 | K013794 |
| LYY | POWDER FREE LATEX EXAMINATION GLOVES WITH ALOE VERA @PH 5.5 AND PROTEIN LABELING CLAIMSLatex Patient Examination Glove | Class 1 | 21 CFR 880.6250 | K013793 |
| LYY | PATIENT EXAMINATION GLOVES (LATEX)Latex Patient Examination Glove | Class 1 | 21 CFR 880.6250 | K892742 |
| LZC | Radiation Attenuation Latex GlovesMedical Glove, Specialty | Class 1 | 21 CFR 880.6250 | K121811 |
| LZC | Biodegradable Powder Free Nitrile Examination Glove,Medical Glove, Specialty | Class 1 | 21 CFR 880.6250 | K202083 |
| LZC | PF Nitrile Exam Glove with pH Coating White-Black ColorMedical Glove, Specialty | Class 1 | 21 CFR 880.6250 | K170290 |
and 25 more on your full dossier
What changed
- Aug 26, 2026Listing added: QDO — Fentanyl And Other Opioid Protection Glove (K252117)
- Aug 26, 2026Listing added: LZC — Medical Glove, Specialty (K252117)
- Aug 26, 2026Listing added: OPJ — Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs (K252117)
- Aug 26, 2026Listing added: LZA — Polymer Patient Examination Glove (K252117)