Browse hierarchy: [General Hospital (HO)](/submissions/HO) → [Subpart G — General Hospital and Personal Use Miscellaneous Devices](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices) → [21 CFR 880.6250](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/880.6250) → LZA — Polymer Patient Examination Glove

# LZA · Polymer Patient Examination Glove

_General Hospital · 21 CFR 880.6250 · Class 1_

**Canonical URL:** https://fda-staging.innolitics.com/productcode/LZA

## Overview

- **Product Code:** LZA
- **Device Name:** Polymer Patient Examination Glove
- **Regulation:** [21 CFR 880.6250](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/880.6250)
- **Device Class:** 1
- **Review Panel:** [General Hospital](/submissions/HO)
- **3rd-party reviewable:** yes

## Identification

A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.

## Classification Rationale

Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.

## Recent Cleared Devices (20 of 1179)

Showing 20 most recent of 1179 cleared devices.

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K262542](/device/K262542.md) | Biodegradable Nitrile Powder Free Examination Glove, Green; Biodegradable Nitrile Powder Free Examination Glove, Violet Blue Tested for Use With 32 Chemotherapy Drugs, Fentanyl & Gastric Acid Permeation Resistance Claim | Top Glove Sdn. Bhd. | Sep 9, 2026 | SESE |
| [K261793](/device/K261793.md) | Powder-free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs and Fentanyl Citrate (Blue and Black Color) | Maxter Healthcare, Inc. | Sep 9, 2026 | SESE |
| [K260312](/device/K260312.md) | Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim; Nitrile Powder Free Examination Glove, Violet Blue Tested for Use with 32 Chemotherapy Drugs, Xylazine, Fentanyl & Gastric Acid | Gmp Medicare Sdn. Bhd. | Sep 8, 2026 | SESE |
| [K260794](/device/K260794.md) | NON-STERILE POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, WITH LICORICE ROOT EXTRACT AND UREA, TESTED FOR USE WITH CHEMOTHERAPY DRUGS, FENTANYL CITRATE, XYLAZINE HCl, AND GASTRIC ACID. OCEAN COLOR | Kossan International Sdn Bhd | Aug 18, 2026 | SESE |
| [K262014](/device/K262014.md) | PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam Gloves | O&M Halyard, Inc. | Jul 21, 2026 | SESE |
| [K254285](/device/K254285.md) | Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Aqua Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Violet Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Dark Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Dark Violet Blue | Hartalega NGC Sdn. Bhd. | Jul 20, 2026 | SESE |
| [K252117](/device/K252117.md) | Biodegradable Powder Free Nitrile Examination Glove, Blue Color, Tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl Citrate-Simulated Gastric Acid Solution | Sw Technologies, Inc. | Jun 24, 2026 | SESE |
| [K253824](/device/K253824.md) | Powder Free Nitrile Examination Gloves Non-Sterile Black | Kanglongda Vietnam Protection Technology Company Limited | Jun 18, 2026 | SESE |
| [K260867](/device/K260867.md) | Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue); Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black) | Hartalega NGC Sdn. Bhd. | Jun 17, 2026 | SESE |
| [K260806](/device/K260806.md) | Nitrile Disposable Examination Gloves | Vista Industries,, LLC | Jun 3, 2026 | SESE |
| [K260703](/device/K260703.md) | Powder Free Blue Nitrile Examination Glove - Tested for Use with Chemotherapy Drugs and Fentanyl;Powder Free Black Nitrile Examination Glove - Tested for Use with Chemotherapy Drugs and Fentanyl | S&S Glove Corporation | Jun 3, 2026 | SESE |
| [K253160](/device/K253160.md) | Syntex Exam Gloves | Basic Medical Technology, Inc. | Jan 23, 2026 | SESE |
| [K252549](/device/K252549.md) | Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Xylazine HCl, and Simulated Gastric Acid; Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Blue), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Xylazine HCl, and Simulated Gastric Acid | Kossan International Sdn Bhd | Jan 13, 2026 | SESE |
| [K251141](/device/K251141.md) | Powder Free Nitrile Patient Examination Glove, Blue colored, Non-sterile Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Patient Examination Glove, Black colored, Non-sterile Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | Mercator Medical (Thailand), Ltd. | Nov 17, 2025 | SESE |
| [K250861](/device/K250861.md) | Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid (Black) | Hartalega NGC Sdn. Bhd. | Oct 23, 2025 | SESE |
| [K252075](/device/K252075.md) | Program insite® Powder-Free, Disposable Nitrile Exam Gloves | Program Insite, LLC | Oct 17, 2025 | SESE |
| [K251716](/device/K251716.md) | Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl Citrate | Basic Medical Technology, Inc. | Aug 27, 2025 | SESE |
| [K252244](/device/K252244.md) | Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, Xylazine, Gastric acid, Fentanyl in Gastric acid and Xylazine in Gastric acid | Ever Global (Vietnam) Enterprise Corporation | Aug 21, 2025 | SESE |
| [K243604](/device/K243604.md) | Halyard Purple Nitrile-XTRA* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Fentanyl Citrate in Simulated Gastric Acid | O&M Halyard, Inc. | Aug 18, 2025 | SESE |
| [K251319](/device/K251319.md) | Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue); Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) – Extended Cuff | Hartalega NGC Sdn. Bhd. | Jul 30, 2025 | SESE |

## Top Applicants

- Hartalega Sdn Bhd — 33 clearances
- Hartalega NGC Sdn. Bhd. — 24 clearances
- Shen Wei (Usa), Inc. — 19 clearances
- Siam Sempermed Corp., Ltd. — 17 clearances
- Smart Glove Corp. Sdn Bhd — 16 clearances

---

**Source:** [https://fda-staging.innolitics.com/productcode/LZA](https://fda-staging.innolitics.com/productcode/LZA)

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