Powder Free Blue Nitrile Examination Gloves

K213107 · Novid Ppe Sdn. Bhd. · LZA · Feb 17, 2022 · General Hospital

Device Facts

• Record ID: K213107
• Device Name: Powder Free Blue Nitrile Examination Gloves
• Applicant: Novid Ppe Sdn. Bhd.
• Product Code: LZA · General Hospital
• Decision Date: Feb 17, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

A 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

Device Story

Disposable synthetic nitrile rubber examination glove; worn on examiner's hand or finger; prevents contamination between patient and examiner. Device provides barrier protection; conforms to hand via tensile properties; strong and flexible. Used in clinical settings; operated by healthcare professionals. Output is physical barrier; affects clinical decision-making by maintaining sterile/clean field during examinations. Benefits patient by reducing risk of infection transmission.

Clinical Evidence

No clinical data. Bench testing only. Performance verified via ASTM D5151 (leak test), ASTM D6319 (physical properties), and ASTM D6124 (residual powder). Biocompatibility testing included ISO 10993-10 (irritation/sensitization) and ISO 10993-11 (systemic toxicity) in animal models, all meeting acceptance criteria.

Technological Characteristics

Synthetic nitrile rubber; non-sterile; powder-free (≤ 2mg/glove); blue colorant. Dimensions: length min 230mm, finger thickness 0.06-0.10mm. Complies with ASTM D6319-10, ASTM D5151, and ASTM D6124. No software or electronic components.

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hand or finger to prevent cross-contamination between patient and examiner.

Regulatory Classification

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

• mCare Powder Free Nitrile Blue Examination Gloves (K172930)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

February 17, 2022

Novid PPE Sdn. Bhd. Er Chuan QA Manager Lot 6071, Jalan Haji Abdul Manan, Batu 5 1/2, Jalan Meru Klang, Selangor 41050 Malaysia

Re: K213107

Trade/Device Name: Powder Free Blue Nitrile Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: September 7, 2021 Received: September 24, 2021

Dear Er Chuan:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Clarence W. Murray, III, PhD Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

510(k) Number (if known)

K213107

Device Name Powder Free Blue Nitrile Examination Gloves

Indications for Use (Describe)

A 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

| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|
| <label><input type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> | <label><input checked="" type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> |

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### K213107

### 510K Summary

### As required by 21 CFR 807.92

### 1) Submission Information:

| Date | : 18th September 2021 |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Type of 510(k) Submission | : Traditional |
| Basis for 510(k) Submission | : New Device |
| Applicant | : Novid PPE Sdn Bhd<br>Lot 6071, Jalan Haji Abdul Manan,<br>Batu 5 ½, Jalan Meru,<br>41050 Klang, Selangor, Malaysia |
| Contact Person | : Er Chai Chuan (QA Manager)<br>Lot 6123, Jalan Haji Salleh,<br>Batu 5 ½, Jalan Meru, 41050 Klang,<br>Selangor, Malaysia.<br>E-mail: [e-mail]<br>Tel: [phone] |

#### 2) Device:

Proprietary Name: Powder Free Blue Nitrile Examination Gloves Classification Name: Examination Gloves Regulation Number: 880.6250 Product Code: LZA Device Class: I Review Panel: General Hospital

### 3) Device Description

The nitrile rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing movements necessary for a medical properties. ASTM conforming tensile properties create a glove that is strong and flexible. The glove is manufactured in accordance with the requirements of ASTM D6319 and ASTM D5151. This is a disposable device, intended for medical purposes, that is worn on the examiner's hand to prevent contamination between patient and examiner.

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## 4) Identification of the Legally Marketed Devices

Class 1 Nitrile Patient Examination Gloves LZA, powder free that meets all the requirements of ASTM standard D6319 and FDA water leak test.

# 5) The Intended Use of Gloves

A Nitrile Examination Glove is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

# Comparison of Technological Characteristics with the Predicate Device: Table 1: General Comparison

| Technological characteristics Comparison to Predicate Device | | | |
|--------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| | Subject Device | Predicate Device | Comparison |
| | Novid PPE Sdn Bhd's<br>Powder Free Blue<br>Nitrile Examination<br>Gloves | Mercator Medical<br>(Thailand) LTD's<br>mCare Powder Free<br>Nitrile Blue<br>Examination Gloves - | |
| 510K Number | K213107 | K172930 | |
| Indications for Use | The device is a<br>disposable device<br>intended for medical<br>purposes that is worn<br>on the examiner's hand<br>or<br>finger to prevent<br>contamination between<br>patient and examiner | The device is a<br>disposable device<br>intended for medical<br>purposes that are worn<br>on the examiner's hand<br>to prevent<br>contamination between<br>patient and examiner. | Same |
| Design Specification | Meet ASTM D6319-10 | Meet ASTM D6319-10 | Same |
| Performance<br>Physical Properties | Meet ASTM D6319-10 | Meet ASTM D6319-10 | Same |
| Material of<br>Composition | Synthetic Nitrile<br>Rubber | Synthetic Nitrile<br>Rubber | Same |
| Biocompatibility:<br>Animal Irritation<br>Test Rabbit | Under the condition of<br>study, not an irritant | Under the condition of<br>study, not an irritant | Same |
| Dermal Sensitization<br>Test- Guinea Pig | Under the condition of<br>study, not a sensitizer | Under the condition of<br>study, not a sensitizer | Same |
| Acute Systemic<br>Cytotoxicity | Under the condition of<br>the study, no adverse<br>biological reaction | Under the condition of<br>the study, no adverse<br>biological reaction | Same |
| Color | Synthetic gloves with<br>embedded colorant-<br>Blue | Synthetic gloves with<br>embedded colorant-<br>Blue | Same |
| Sterility | Non-Sterile | Non-Sterile | Same |
| | | | |
| Powder Free | Meets applicable definition for Powder free; ≤ 2mg per glove | Meets applicable definition for Powder free; ≤ 2mg per glove | Same |
| Labelling<br>Information | Single Use indication, Powder free, device name, gloves size, quantity, Patient examination gloves, Non-sterile | Single Use indication, Powder free, device name, gloves size, quantity, Patient examination gloves, Non-sterile | Same |
| Physical<br>Properties<br>as per<br>ASTM<br>D6319-10 | <b>Before Aging</b><br>Tensile Strength<br>Min 14 MPa<br>Ultimate Elongation<br>Min 500%<br><b>After Aging</b><br>Tensile Strength<br>Min 14 MPa<br>Ultimate Elongation<br>Min 400% | <b>Before Aging</b><br>Tensile Strength<br>Min 14 MPa<br>Ultimate Elongation<br>Min 500%<br><b>After Aging</b><br>Tensile Strength<br>Min 14 MPa<br>Ultimate Elongation<br>Min 400% | Same |
| Dimension<br>as per<br>ASTM<br>D6319-10 | Finger Thickness:<br>0.06 - 0.10 mm<br>Length: min 230 mm | Finger Thickness:<br>Min 0.05 mm Length:<br>min 230 mm | Similar |
| Freedom<br>from holes | AQL per CFR<br>21.800.20<br>Test as per ASTM<br>D5151 | AQL per CFR<br>21.800.20<br>Test as per ASTM<br>D5151 | Same |
| Residual<br>Powder | Tested to ASTM<br>D6124 and meets<br>requirement | Tested to ASTM<br>D6124 and meets<br>requirement | Same |

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### 6) Non-clinical test was performed on the proposed device:

Non-clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards:

- a) ISO 10993-10:2010 Biological evaluation of medical devices- Part 10: Tests for Irritation and Skin Sensitization
- b) ISO 10993-11- Biological Evaluation of Medical devices- Part 11: Tests for Systemic toxicity
- c) ASTM D6124-06 (Reapproved 2017), Standard test method for Residual powder on medical gloves
- d) ASTM D5151-06 (Reapproved 2015), Standard Test Method for Detection of Holes in medical gloves
- e) ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application

Performance data of gloves based on ASTM D6977 and FDA Watertight Test In addition the proposed device was tested and conformed to the following standards and requirements stated in guidance for industry passed and FDA staff - Premarket Notification [510(k)] Submission issued on March 5, 2004:

Table 2: Performance Testing Performance data of gloves and Biocompatibility Testing based on animal studies, biocompatibility studies i) Skin irritation in rabbits, Guinea pig sensitization (Buehler) and acute systemic cytotoxicity test were conducted on Novid PPE Sdn Bhd's final and finished Powder Free Blue Nitrile Examination Gloves.

| Test Method | Purpose | Acceptance<br>Criteria | Powder Free Blue Nitrile<br>Examination<br>Gloves Results |
|-------------|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------|
| ASTM D 5151 | Pinhole Test | Free from holes,<br>AQL 1.5 | Pass |
| ASTM D6319 | Physical Properties | Before Aging<br>Tensile Strength:<br>Min 14 MPa<br>Elongation: Min<br>500%<br>After Aging<br>Tensile Strength:<br>Min 14 MPa<br>Elongation: Min<br>400% | Pass |

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| 1. Watertight (1000mL)<br>in accordance with<br>ASTM D5151 | Leak Test | Single Sampling<br>in accordance<br>with ISO 2859<br>G1 : AQL 2.5 | Pass G1 : AQL 2.5 | |
|------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. Length (mm) Size | Physical Properties | | | |
| S | | Min 220 | 240mm minimum for all<br>sizes | |
| M | | Min 230 | | |
| L | | Min 230 | | |
| XL | | Min 230 | | |
| 3. Palm width (mm) Size | Physical Properties | | | |
| S | | 80 ± 10 | 84 – 86 | |
| M | | 95 ± 10 | 95-96 | |
| L | | 110 ± 10 | 108 – 109 | |
| XL | | 120 ± 10 | 114 - 115 | |
| 4. Thickness (mm)<br>Single Layer Finger | Physical Properties | | | |
| Palm | | Min 0.05 | Min 0.06 | |
| Cuff | | Min 0.05 | Min 0.06 | |
| | | Min 0.05 | Min 0.05 | |
| 5. Physical Properties in<br>accordance with ASTM D412 | Physical Properties | | | |
| <b>Before Aging</b> | | | | |
| Tensile Strength (MPa) | | Min 14 | 17 – 23 | |
| Ultimate Elongation (%) | | Min 500 | 540 – 607 | |
| <b>After Aging</b> | | | | |
| Tensile Strength (MPa) | | Min 14 | 21 – 27 | |
| Ultimate Elongation (%) | | Min 400 | 480 - 565 | |
| 6. Powder Content in accordance<br>with ASTM D6124 | Powder Residue | Max 2.0 mg/ glove | Below 2.0 mg/ glove | |
| I. Guinea Pig<br>Sensitization | This test was<br>designed to<br>determine if the<br>test article is a<br>potential sensitizer<br>to guinea pigs<br>when applied<br>atopically. | No deviations were<br>noted, observed<br>nor require<br>clarification. | No reaction was observed<br>upon removal of the test<br>material and there was no<br>positive allergic reaction<br>observed on the test of<br>guinea pigs during the<br>challenge phase. None of<br>the guinea pigs was<br>sensitized.<br>Conclusion: meets<br>conformance<br>requirements | |
| II. Primary Dermal | This test was<br>designed to | No deviations were<br>noted, observe nor | Each test was<br>individually | |
| | Irritation in Rabbits | identify substances which are primary irritants to rabbit skin | require clarification. | examined and scored at 24 $\pm$ 2,<br>48 $\pm$ 2 and 72 $\pm$ 2 hours for erythema and edema using the Draize skin scoring scale. Results obtained as Primary Irritation Index was 0. Conclusion: meets conformance requirements. |
| III. | Acute Systemic Cytotoxicity in Rats | This test was designed to identify any adverse biological reaction following administration of the extracts of the test item on the rats. | No adverse reaction was noted, observed nor require clarification. | For the 4 days observation done on the test subject by doing:<br>1) Cage- side observation- all animals survived and appeared healthy and active through out of 4 days.<br>2) Body weight- all animals gained body weight through out of the 4 days. |

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| | | 3) Pathology- |
|--|--|----------------|
| | | At sacrifice |
| | | times, gross |
| | | necropsies |
| | | showed no |
| | | abnormalities |
| | | for any of the |
| | | animals. |
| | | Conclusion: |
| | | meets |
| | | conformance |
| | | requirements. |

### 7) Clinical Test Conclusion

No clinical study is included in this submission

# 8) Conclusion

The conclusions drawn from the non-clinical tests demonstrate that the subject device is as safe, as effective, and perform as well as or better than the legally marketed predicated K172930.