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Sign in to claim this brandSEMPERMED USA, INC.
US
Last updated May 24, 2026
What SEMPERMED USA, INC. makes
The company manufactures single-use gloves for medical examination and surgical procedures, including nitrile, polyisoprene, polychloroprene, vinyl, and latex varieties. These products are available in both examination/treatment and surgical grades, with most formulations specified as non-powdered and non-antimicrobial. Examples include sterile and non-sterile nitrile gloves, latex examination gloves, and UV-treated polyisoprene surgical gloves.
All listed devices fall under FDA Class I regulation, with authorisations granted through 510(k) premarket notifications and the FDA’s Unique Device Identification (UDI) system. The company’s products are registered in the United States, where they comply with domestic medical device requirements.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Sempermed USA, Inc. manufacture?
Sempermed USA, Inc. specializes in single-use medical gloves for examination, treatment, and surgical procedures. Their product line includes gloves made from nitrile, polyisoprene, polychloroprene, vinyl, and latex materials. These gloves are designed for both examination/treatment and surgical use, with most formulations available in non-powdered and non-antimicrobial versions. Examples include sterile and non-sterile nitrile gloves, latex examination gloves, and UV-treated polyisoprene surgical gloves.
Where is Sempermed USA, Inc. based, and what regulatory requirements do their devices comply with?
Sempermed USA, Inc. is based in the United States. Their devices are registered domestically and comply with U.S. medical device regulations. Since all their products fall under FDA Class I classification, they are authorised through the FDA’s 510(k) premarket notification process and are listed in the FDA’s Unique Device Identification (UDI) system. This classification applies to low-risk devices like single-use gloves, which typically undergo less stringent review compared to higher-risk medical devices.
Which regulatory registries or databases list Sempermed USA, Inc.’s medical devices?
Sempermed USA, Inc.’s medical devices are listed in the FDA’s 510(k) premarket notification database and the FDA’s Unique Device Identification (UDI) system. These registries track devices that have received FDA authorisation, ensuring transparency and compliance with U.S. medical device regulations. The UDI system, in particular, helps identify and track devices throughout their lifecycle, including manufacturing, distribution, and use.
How are Sempermed USA, Inc.’s gloves classified by regulatory authorities?
Sempermed USA, Inc.’s gloves are classified as FDA Class I devices. This classification is assigned based on the risk level of the product—single-use gloves are considered low-risk due to their minimal potential for harm if used as intended. Class I devices typically require general controls (such as good manufacturing practices) and may not need a premarket submission unless they are new or significantly modified. However, they must still comply with applicable regulations, including registration, listing, and UDI requirements.
Are Sempermed USA, Inc.’s gloves available in sterile and non-sterile versions, and how does this affect their use?
Yes, Sempermed USA, Inc. offers both sterile and non-sterile gloves in their product line, particularly in nitrile and latex varieties. Sterile gloves are designed for surgical procedures where maintaining a sterile field is critical, while non-sterile gloves are typically used for examination or treatment where sterility is not required. The distinction between sterile and non-sterile versions ensures the appropriate product is selected based on the clinical setting and procedure, adhering to best practices for infection control and patient safety.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- sempermedusa.com
- —
- —
- [email protected]
- Phone
- 800-366-9545
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 004072158
Catalogue (321)
Page 2 of 7| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| StarMed Ultra Nitrile Exam Glove | SMTN254 | FDA UDI | Class I | Unknown |
| Sempermed skySense | BBLN304 | FDA UDI | Class I | Unknown |
| SemperShield CR Chloroprene Exam Glove | SSCR104 | FDA UDI | Class I | Active |
| Xpert | SGXN 105 | FDA UDI | Class I | Unknown |
| SemperSure Nitrile Exam Glove | SUNF201 | FDA UDI | Class I | Active |
| Best Touch Nitrile Exam Glove | BTNA205 | FDA UDI | Class I | Active |
| Sempermed Syntegra IR Polyisoprene Surgical Glove | SIR750 | FDA UDI | N/A | Active |
| Sempermed Syntegra CR Chloroprene Surgical Glove | SCR550 | FDA UDI | Class I | Active |
| Sempermed Supreme Latex Surgical Glove | SPK-SPFP | FDA UDI | Class I | Active |
| velvet 300 | SMNP305 | FDA UDI | Class I | Unknown |
| StarMed Ultra/Tender Touch Nitrile Exam Glove | SPK-035VB | FDA UDI | Class I | Active |
| Sempermed Supreme Latex Surgical Glove | SPFP550 | FDA UDI | Class I | Active |
| SemperCare Vinyl Exam Glove | EVNP105 | FDA UDI | Class I | Active |
| SemperCare Nitrile Exam Glove | SPK-NIPFT | FDA UDI | Class I | Active |
| SemperCare Latex Exam Glove | SCLT101 | FDA UDI | Class I | Active |
| Sempermed Supreme Latex Surgical Glove | SPFP750 | FDA UDI | Class I | Active |
| StarMed Plus Nitrile Exam Glove | SMNP301 | FDA UDI | Class I | Unknown |
| SemperSure Black Nitrile Exam Glove | SUNB102 | FDA UDI | Class I | Active |
| force+ | SSEC102 | FDA UDI | Class I | Unknown |
| SemperShield EC Nitrile Exam Glove | SSEC102 | FDA UDI | Class I | Active |
| Sempermed iconiX bi-fusion | SPK-ICNX | FDA UDI | Class I | Unknown |
| StarMed Sterile Nitrile Exam Glove | SMSN102 | FDA UDI | Class I | Active |
| StarMed Black Nitrile Exam Glove | SMNB105 | FDA UDI | Class I | Active |
| StarMed Select Nitrile Exam Glove | SMNS103 | FDA UDI | Class I | Active |
| force black | BKNF103 | FDA UDI | Class I | Unknown |
| safe | BLNF105 | FDA UDI | Class I | Unknown |
| SemperCare Nitrile Exam Glove | NIPFT104 | FDA UDI | Class I | Active |
| Xpert | SGXN 104 | FDA UDI | Class I | Unknown |
| SemperShield Black Nitrile Exam Glove | SPK-SSBN | FDA UDI | Class I | Active |
| Sempermed skySense | BBLN301 | FDA UDI | Class I | Unknown |
| Sempermed skySense | BBLN302 | FDA UDI | Class I | Unknown |
| Generic Black Nitrile Exam Glove | GBKN104 | FDA UDI | Class I | Active |
| Sempermed Syntegra UV Polyisoprene Surgical Glove | SUV800 | FDA UDI | N/A | Active |
| safe | SPK-BLNF | FDA UDI | Class I | Unknown |
| SemperShield Nitrile Exam Glove | SSNF102 | FDA UDI | Class I | Active |
| safe sterile | SSN102 | FDA UDI | Class I | Unknown |
| SemperSure Green Nitrile Exam Glove | SUNG202 | FDA UDI | Class I | Active |
| safe | BLNF104 | FDA UDI | Class I | Unknown |
| Sempermed vinyl syn-stretch Exam Glove | SCVNP103 | FDA UDI | Class I | Unknown |
| Sempermed skySense | BBLN303 | FDA UDI | Class I | Unknown |
| Sempermed iconiX bi-fusion | ICNX 106 | FDA UDI | Class I | Unknown |
| Tender Touch 100 Nitrile Exam Glove | TTNF102 | FDA UDI | Class I | Active |
| Sempermed iconiX bi-fusion | ICNX 102 | FDA UDI | Class I | Unknown |
| SemperShield Black Nitrile Exam Glove | SSBN104 | FDA UDI | Class I | Active |
| Sempermed Syntegra IR Polyisoprene Surgical Glove | SIR800 | FDA UDI | N/A | Active |
| SemperForce Orange Nitrile Exam Glove | SPK-ORNF | FDA UDI | Class I | Active |
| Tender Touch 100 Nitrile Exam Glove | TTNF105 | FDA UDI | Class I | Active |
| StarMed Ultra Nitrile Exam Glove | SMTN251 | FDA UDI | Class I | Unknown |
| StarMed Select Nitrile Exam Glove | SMNS105 | FDA UDI | Class I | Active |
| green x-free | SUNG205 | FDA UDI | Class I | Unknown |
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