Nitrile Patient Examination Gloves, Powder Free

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K220697 ↗

FDA Product Code

LZA

FDA applicant

Lalan Rubbers (Pvt), Ltd.

Device Class

Class I

Regulation

21 CFR Part 880.6250

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Ls 02

  Class IIa

  CE/MDR

• NE 002- Size 8.5

  Class I

  CE/MDR

• NE 002- Size 6

  Class I

  CE/MDR

• LS 01- Size 7.5

  Class IIa

  CE/MDR

• LS 01- Size 7

  Class IIa

  CE/MDR

• LS 01- Size 6

  Class IIa

  CE/MDR

See all devices from Lalan Rubbers (Pvt) Ltd. →

• Are these gloves suitable for reuse in clinical settings, or are they meant for single-use only?

  These gloves are explicitly designed for single-use in clinical settings, such as general hospitals. The manufacturer and regulatory filings (including FDA 510(k) clearance) confirm they are not intended for reuse, ensuring compliance with infection control protocols.

• What sizes and models are available for the Nitrile Patient Examination Gloves?

  The provided data does not specify exact sizes or model variants, but as Polymer Patient Examination Gloves (Product Code LZA), they are likely offered in standard clinical sizes (e.g., small, medium, large) common for patient examinations. For precise sizing details, contact the manufacturer, Lalan Rubbers (Pvt) Ltd.

• How are these gloves supplied, and are they sterile?

  The gloves are supplied sterile, as noted in the regulatory summary. They come pre-packaged for clinical use, ensuring no additional sterilization is required before application. This aligns with their intended single-use purpose in healthcare settings.

• What regulatory pathways have these gloves followed, and how does that affect their use?

  These gloves are cleared under FDA 510(k) (K220697) and comply with MDR (Medical Device Regulation) standards. The clearance confirms they meet U.S. safety and performance requirements for Polymer Patient Examination Gloves (Product Code LZA), while MDR compliance ensures adherence to EU regulations. Both pathways validate their suitability for single-use in clinical environments like general hospitals.

• How should these gloves be stored to maintain their integrity?

  While the data doesn’t specify storage conditions, standard practice for sterile, single-use nitrile gloves—especially those cleared under FDA 510(k)—recommends storing them in a cool, dry place, protected from direct sunlight or extreme temperatures. Check the packaging for any manufacturer-specific instructions, as improper storage could compromise sterility or material integrity.