← Product Code [LZA](/productcode/LZA) · K162510

# Non-Sterile, Powder-Free, Nitrile Examination Gloves, Blue (K162510)

_Ug Global Resources Sdn. Bhd. · LZA · Jul 18, 2017 · General Hospital · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K162510

## Device Facts

- **Applicant:** Ug Global Resources Sdn. Bhd.
- **Product Code:** [LZA](/productcode/LZA.md)
- **Decision Date:** Jul 18, 2017
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 880.6250
- **Device Class:** Class 1
- **Review Panel:** General Hospital

## Indications for Use

Non-Sterile, Powder-Free, Nitrile Examination Gloves, Blue is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between the patient and the examiner.

## Device Story

Disposable nitrile examination glove; worn on examiner's hand or finger; prevents contamination between patient and examiner. Used in medical settings; provides barrier protection. Device is blue, powder-free, and features beaded cuff. Manufactured to meet ASTM D6319-10 standards for physical properties and dimensions. Biocompatibility testing confirms non-irritating and non-sensitizing properties.

## Clinical Evidence

Bench testing only. Testing included physical property evaluation (tensile strength, elongation), dimensions, water-tight testing (ASTM D5151-06), powder residue analysis (ASTM D6124-06), and biocompatibility (dermal sensitization and primary skin irritation per ISO 10993-10 and 16 CFR Part 1500).

## Technological Characteristics

Material: Nitrile. Design: Beaded cuff, powder-free (max 2mg/glove). Standards: ASTM D6319-10 (dimensions, physical properties, residue), ASTM D5151-06 (water leak). Biocompatibility: ISO 10993-10. Sizes: XS-XL. Non-sterile.

## Regulatory 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.

## Predicate Devices

- Non-Sterile, Powder-Free, Blue, Nitrile Examination Gloves ([K112012](/device/K112012.md))

## Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 18, 2017

UG Global Resources Sdn. Bhd. % Kenneth Stanton President UG Healthcare (USA) Inc. 1565 Sunflower Ave Costa Mesa, California 92626

Re: K162510

Trade/Device Name: Non-Sterile, Powder-Free, Nitrile Examination Gloves, Blue Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LZA Dated: June 20, 2017 Received: January 19, 2017

Dear Kenneth Stanton:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

# Mark S. Fellman -S

for

Lori Wiggins, MPT, CLT Acting Director Division of Anesthesiology, General Hospital. Respiratory. Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K162510

#### Device Name

Non-Sterile, Powder-Free, Nitrile Examination Gloves, Blue

Indications for Use (Describe)

Non-Sterile, Powder-Free, Nitrile Examination Gloves, Blue is a disposable device intended for medical purposes that is worn on the examiner 's hand or finger to prevent contamination between the examiner

| Type of Use (Select one or both, as applicable) |  |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

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# SUMMARY

## PREMARKET 510(k) NOTIFICATION Non-Sterile, Powder-Free, Nitrile Examination Gloves, Blue K162510

Submission Applicant:

UG Global Resources Sdn Bhd 1st Floor No. 18 Jalan Dato'Abd Rahman 70000 Seremban Negeri Sembilan Darul Khusus, Malaysia Telephone No .: 60-06-6772751 Fax:60-06-6772755

Official Correspondent: Kenneth J. Stanton, President UG Healthcare (USA) Inc. 1565 Sunflower Avenue Costa Mesa, Ca 92626 Tel: (714)444-2248 Fax: (714)444-2271

Date: June 8, 2017

Description of the Device: Non-Sterile, Powder-Free, Nitrile Examination Gloves, Blue

Trade Name: Non-Sterile, Powder-Free, Nitrile Examination Gloves, Blue

Common Name: Nitrile Examination Gloves Classification Name: Patient Examination Glove (per 21 CFR 880.6250) Class 1: Powder-Free Nitrile examination glove LZA that meets all of the requirements of ASTM 6319-10.

Predicative Devices (K112012):Non-Sterile, Powder-Free, Blue, Nitrile Examination Gloves

Device Description: The subject device of this submission is a Nitrile Examination Glove. The glove is non-sterile and meets the recommendations of ASTM 6319-10 . The device is Blue in color.

Indications for Use: Non-Sterile, Powder-Free, Nitrile Examination Gloves, Blue is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between the patient and the examiner.

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# SUMMARY

PREMARKET 510(k) NOTIFICATION

Non-Sterile, Powder-Free, Nitrile Examination Gloves, Blue

# Summary of Technological Characteristics:

Material: Nitrile Cuff: Beaded Powder Residue: Maximum 2mg/glove

| Characteristics                                    | Standards                                                 | Device Performance              |
|----------------------------------------------------|-----------------------------------------------------------|---------------------------------|
| Dimensions                                         | ASTM D 6319-10                                            | Inspection Level-S-<br>2 AQL4.0 |
| Physical Properties                                | ASTM D 6319-10                                            | Inspection Level-S-2<br>AQL4.0  |
| Freedom from Pinholes – Water Tight<br>Test 1000ML | ASTM D 6319-10<br>ASTM D 5151-06                          | Inspection Level-G-1<br>AQL 1.5 |
| Powder-Free Residue-                               | ASTM D 6319-10<br>ASTM D 6124-06                          | Maximum 2mg/glove               |
| Biocompatibility                                   | Dermal Sensitization<br>(as per ISO 10993-10)             | Not a contact skin sensitizer   |
|                                                    | Primary Skin Irritation Test<br>(as per 16 CFR Part 1500) | Not a primary skin irritant     |

Packaging: 100 pieces per dispenser box, 10 boxes per case, 1,000 gloves per case

Sizes: XS -XL

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Substantial Equivalence Table-

|                                | Color | Material | Biocompatibility Tests                                                                                               | ASTM D3578-05(2015)<br>Tensile Strength (MPa) | ASTM D3578-<br>05(2015)<br>Elongation % |
|--------------------------------|-------|----------|----------------------------------------------------------------------------------------------------------------------|-----------------------------------------------|-----------------------------------------|
| Subject<br>Device<br>K162510   | Blue  | Nitrile  | ISO 10993-10 - Primary Irritation Test- Under the<br>conditions of the study, the device is non-irritating           | Before Aging- min 14.0                        | Before Aging - min<br>500               |
|                                |       |          | ISO 10993-10 - Dermal Sensitization Assay -<br>Under the conditions of the study, the device is a<br>non-sensitizer  | After Aging - min 14.0                        | After Aging - min.<br>400               |
| Predicate<br>Device<br>K112012 | Blue  | Nitrile  | ISO 10993-10 - Dermal Sensitization Assay - Under<br>the conditions of the study, the device is a non-<br>sensitizer | Before Aging- min 14.0                        | Before Aging- min.<br>500               |
|                                |       |          | ISO 10993-10 - Primary Irritation Test- Under the<br>conditions of the study, the device is non-irritating           | After Aging- min 14.0                         | After Aging - min.<br>400               |

|  | Subject Device | Dimensions                                                                                                 | Waterleak | Powder Content                     |  |
|--|----------------|------------------------------------------------------------------------------------------------------------|-----------|------------------------------------|--|
|  | K162510        | Palm Width - 95mm +/-10 Medium size<br>Length: 240mm min<br>Thickness: Min .05mm Palm and finger           | AQL 1.5   | Max 2.0mg/glove<br>Avg 1.0mg/glove |  |
|  |                |                                                                                                            |           |                                    |  |
|  | K112012        | Palm Width- 95mm +/- 10 Medium size<br>Length: 240mm min<br>Thickness: Min .15mm Palm and Min .17mm finger | AQL 1.5   | Max 2.0mg/glove<br>Avg .22mg/glove |  |

|                                | Sizes | Single Use | Indications for Use                                                                                                                                                                     |
|--------------------------------|-------|------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Subject<br>Device<br>K162510   | XS-XL | Yes        | A patient examination glove is a disposable device intended for medical purposes that is worn on the<br>examiner's hand or finger to prevent contamination between patient and examiner |
| Predicate<br>Device<br>K112012 | XS-XL | Yes        | A patient examination glove is a disposable device intended for Medical Purposes that is worn on the<br>examiner's hand or finger to prevent contamination between patient and examiner |

Comparisons-Both K162510 and K112012 are Non-Stelle Examination Gloves. Both have the same specifications exept for thickness, both have the same AQ. 1.5 for pinholes and similar powder content. Both gloves have be matility Test. Additionally, both devices have similar tensile strength and elongation performance.

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## Conclusion:

This product is as safe, as effective, and performs as well or better than the legally marketed device K112012 (Non-Sterination Gloves),

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**Source:** [https://fda-staging.innolitics.com/device/K162510](https://fda-staging.innolitics.com/device/K162510)

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