PPS MANUFACTURING
Bulgaria BG-MF-000026135 Last updated 21 Oct 2026
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- Devices
- 10
- Registries
- EUDAMED
- FDA recalls
- 0
Catalogue
Safe Care – 3.5G Blue Nitrile Examination Gloves Ref PPS-SC-04
Black Label – 3.5G Black Nitrile Examination Gloves Ref PPS-BL-03
Black Label – 3.5G Black Nitrile Examination Gloves Ref PPS-BL-05
Safe Care – 3.5G Blue Nitrile Examination Gloves Ref PPS-SC-02
Safe Care – 3.5G Blue Nitrile Examination Gloves Ref PPS-SC-01
Safe Care – 3.5G Blue Nitrile Examination Gloves Ref PPS-SC-03
Safe Care – 3.5G Blue Nitrile Examination Gloves Ref PPS-SC-05
Black Label – 3.5G Black Nitrile Examination Gloves Ref PPS-BL-01
Black Label – 3.5G Black Nitrile Examination Gloves Ref PPS-BL-02
Black Label – 3.5G Black Nitrile Examination Gloves Ref PPS-BL-04
About
In today’s environment, maintaining impeccable hygiene is essential and can be a real challenge. PPS Gloves offers a comprehensive range of protective nitrile gloves, providing smart solutions for safer workplaces.
What PPS MANUFACTURING makes
PPS Manufacturing produces single-use nitrile examination gloves in two styles: blue and black, both rated at 3.5G puncture resistance. These gloves are designed for medical and clinical examinations, ensuring barrier protection against contaminants during procedures.
The company’s nitrile gloves are classified as Class I medical devices and are registered in the EU via the eudamed database. The manufacturer is based in Bulgaria.
Frequently asked questions
What types of medical devices does PPS Manufacturing produce?
PPS Manufacturing specializes in single-use nitrile examination gloves. Their product line includes two styles: blue and black nitrile gloves, both rated for 3.5G puncture resistance. These gloves are designed specifically for medical and clinical examinations to provide barrier protection against contaminants during procedures.
Where is PPS Manufacturing based?
PPS Manufacturing is headquartered in Bulgaria. The company’s location is relevant for understanding its regulatory scope, particularly in the European market.
How are PPS Manufacturing’s nitrile gloves classified under medical device regulations?
PPS Manufacturing’s nitrile examination gloves are classified as Class I medical devices. This classification is determined by their intended use—low-risk, non-invasive procedures like examinations—and aligns with EU regulatory frameworks, where such devices typically require less stringent scrutiny than higher-risk categories.
Are PPS Manufacturing’s devices listed in any regulatory databases?
Yes, PPS Manufacturing’s nitrile examination gloves are registered in the eudamed database. This EU-wide registry ensures transparency and traceability for medical devices marketed within the European Union, allowing healthcare professionals and regulators to verify compliance and details about the manufacturer’s products.
Information
- Country
- Bulgaria
- Address
- 8, Ul. Tsar Kaloyan, Sofia, Bulgaria
- Website
- www.ppsmanufacture.com/en/
- [email protected]
- Phone
- +359 88 8523416
- PRRC contact
- Georgi Petkov
- EUDAMED SRN
- BG-MF-000026135