Proguard, RR-1, RR-2

Q: What is the product code of K982832?

The FDA product code is LZC – Medical Glove, Specialty, a Class I (low risk) device regulated under 21 CFR 880.6250.

FDA 510(k) K982832 · Emerson & Co. Srl

Substantially Equivalent

510(k) numberK982832

Submission

Device name: Proguard, RR-1, RR-2
Applicant: Emerson & Co. Srl
Genoa, IT
Received: August 12, 1998
Decision date: December 23, 1998
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: LZC – Medical Glove, Specialty
Device class: Class I (low risk)
Regulation: 21 CFR 880.6250
Specialty: General Hospital

A disposable medical glove (examination or surgeons) is a device that may or may not bear a trace amount of residual powder and is intended to be worn on the hand or finger(s) for medical purposes to prevent contamination. In addition, these gloves may have specialty claims such as chemotherapy, etc.

Other 510(k)s with product code LZC

510(k)	Device	Applicant	Decision
K252313	Cardinal Health Nitrile Examination Gloves Extended CuffLZC · Traditional	Cardinalhealth	01/14/2026SE
K243959	Powder Free Nitrile Examination Gloves (Violet, Black, Green), Tested for Use with…LZC · Traditional	Lingshi Hongruida Health Protection Technology…	02/24/2025SE
K221157	JR MedicLZC · Abbreviated	Jr Engineering & Medical Technologies (M) Sdn.…	08/30/2022SE
K222449	Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs And…LZC · Traditional	Better Care Plastic Technology Co., Ltd.	08/27/2022SE
K220545	Powder Free Nitrile Examination Gloves, Blue, Tested for use with Chemotherapy DrugsLZC · Traditional	Hl Rubber Industries Sdn Bhd	05/26/2022SE
K220491	Disposable Medical Nitrile Examination Gloves -Tested for Use with Chemotherapy DrugsLZC · Traditional	Hainan Asther Medical Equipment Co., Ltd.	05/14/2022SE
K220353	Disposal Medical Nitrile Examination Gloves-Tested for Use with Chemotherapy DrugsLZC · Traditional	Niujian Technology Co., Ltd.	03/31/2022SE
K213910	Disposable Medical Nitrile Examination Gloves- Tested for Use with Chemotherapy DrugsLZC · Traditional	Changzhou Universal Medical Equipment Co., Ltd.	03/10/2022SE
K213325	Disposable Medical Nitrile Examination Gloves- Tested for Use With Chemotherapy DrugsLZC · Traditional	Anhui Xinyisheng Medical Technology Co.,Ltd	01/28/2022SE
K213076	AspenMed+LZC · Abbreviated	Aspen Glove Sdn. Bhd.	12/20/2021SE

More from Aspen Glove Sdn. Bhd.

510(k)	Device	Decision
K192933	Polyisoprene Powder Free, Black Colour Surgical GlovesKGO · Special	01/13/2021SE
K151228	PROGUARD Polyisoprene Powder Free, Black Colour Surgical Gloves, Model 1: .22mm Model 2:…KGO · Traditional	01/15/2016SE

Questions and answers

When was Proguard, RR-1, RR-2 cleared by the FDA?

Proguard, RR-1, RR-2 (K982832) received a 510(k) decision of Substantially Equivalent on December 23, 1998, 133 days after the submission was received.

What is the product code of K982832?

The FDA product code is LZC – Medical Glove, Specialty, a Class I (low risk) device regulated under 21 CFR 880.6250.