Nitrile Exam Gloves (Blue, Black)

K221143 · Hebei Astro Medical Supply Co., Ltd. · LZA · Aug 25, 2022 · General Hospital

Device Facts

• Record ID: K221143
• Device Name: Nitrile Exam Gloves (Blue, Black)
• Applicant: Hebei Astro Medical Supply Co., Ltd.
• Product Code: LZA · General Hospital
• Decision Date: Aug 25, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

Nitrile Exam Gloves (Blue, Black) is a disposable device intended for medical purpose that is worn on the examiner's hands to prevent contamination between patient and examiner.

Device Story

Disposable nitrile examination gloves; worn on examiner's hands; barrier protection to prevent cross-contamination between patient and examiner. Available in blue and black; six sizes (XS-XXL). Non-sterile; powder-free. Used in clinical settings; operated by healthcare professionals or other users requiring barrier protection. Physical properties and dimensions verified against ASTM standards. Benefits include reduction of contamination risk during medical examinations.

Clinical Evidence

No clinical data. Bench testing only. Compliance verified via ASTM D6319-19 (dimensions, physical properties, residual powder), ASTM D5151-19 (freedom from holes), and ISO 10993-10/11 (biocompatibility: sensitization, intracutaneous reactivity, systemic toxicity).

Technological Characteristics

Material: Nitrile. Form: Powder-free, non-sterile, single-use glove. Dimensions/Physical Properties per ASTM D6319-19, ASTM D412-16, ASTM D3767-03, ASTM D6124-06. Biocompatibility per ISO 10993-10 and ISO 10993-11. No software or electronic components.

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hands to prevent 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

• Powder Free Nitrile Examination Gloves, (Blue, Black, Indigo) (K211457)

Submission Summary (Full Text)

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August 25, 2022

Hebei Astro Medical Supply Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co.,Ltd. P.O.box 120-119 Shanghai. 200120 China

Re: K221143

Trade/Device Name: Nitrile Exam Gloves (Blue, Black) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: July 25, 2022 Received: July 25, 2022

Dear Diana Hong:

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); medical device reporting (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/combinationproducts/guidance-regulatory-information/postmarketing-safety-reporting-combination-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, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality 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) K221143

Device Name

Nitrile Exam Gloves (Blue, Black)

Indications for Use (Describe)

Nitrile Exam Gloves (Blue, Black) is a disposable device intended for medical purpose that is worn on the examiner's hands to prevent contamination between patient and 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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# 510(k) Summary

This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.

The assigned 510(k) Number: K221143

- 1. Date of Preparation: 8/23/2022
- 2. Sponsor Identification

### Hebei Astro Medical Supply Co., Ltd.

Address: East of Xiaoxixian, West of Jingsan Street, South of Weiwu Road, North of Weigi Road,

Jinzhou Economic Development Zone, Hebei Province, P.R, China, 052260

Establishment Registration Number: 3015537296

Contact Person: Ning Zheng

Position: General Manager

Tel: [phone]

Email: [e-mail]

- Designated Submission Correspondent 3.
Ms. Diana Hong (Primary Contact Person)

Ms. Jinlei Tang (Alternative Contact Person)

#### Mid-Link Consulting Co., Ltd

P.O. Box 120-119, Shanghai, 200120, China

Tel: [phone],

Fax: [phone]

Email: [e-mail]

- 4. Identification of Proposed Device
Trade Name: Nitrile Exam Gloves (Blue, Black)

Common Name: POWDER FREE NITRILE EXAMINATION GLOVES

#### Regulatory Information

Classification Name: polymer patient examination glove

Classification: I;

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Product Code: LZA; Regulation Number: 21CFR 880.6250 Review Panel: General Hospital;

### Indication for Use:

Nitrile Exam Gloves (Blue, Black) is a disposable device intended for medical purpose that is worn on the examiner's hands to prevent contamination between patient and examiner.

Device Description

The proposed device is a power free medical glove. The device is provided in blue and black. The device meets the requirements of ASTM D6319-19: Standard specification for Nitrile Examination Gloves for Medical Application. The proposed gloves are available in six sizes, which are XS, S, M, L, XL, XXL, it could be selected by the user depended on size of hand. The different between each size is just in the dimension. The proposed device is provided in non-sterile.

- 5. Identification of Predicate Device
510(k) Number: K211457 Product Name: Powder Free Nitrile Examination Gloves, (Blue, Black, Indigo)

- 6. Summary of Technological characteristics

| ITEM | Proposed Device | Predicate Device K211457 | Comparison |
|------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Product Code | LZA | LZA | Same |
| Regulation<br>Number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Class | I | I | Same |
| Indication for use | Nitrile Exam Gloves<br>(Blue, Black) is a<br>disposable device intended<br>for medical purpose that is<br>worn on the examiner's hands<br>to prevent contamination<br>between patient and examiner. | The Powder Free Nitrile<br>Examination Gloves is a<br>disposable device intended for<br>medical purpose that is worn on<br>the examiner's hands to prevent<br>contamination between patient<br>and examiner. | Same |
| Material | Nitrile | Nitrile | Same |
| Color | Blue, Black | Blue, Black, Indigo | Different |
| Sterility | Non-sterile | Non-sterile | Same |
| Single-use | Yes | Yes | Same |
| Surface Treatment<br>/Powder or<br>Powder Free | Powder Free | Powder Free | Same |

Table 1 Comparison of Technology Characteristics

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| Size | XS, S, M, L, XL, XXL | | XS, S, M, L, XL | | Different |
|------------------------------------------------------------------|-------------------------------------------------------|------------|----------------------------------------------------|--------------|-----------|
| | Width | | | | |
| | XS | 75±5mm | XS | 70±10mm | |
| | S | 85±5mm | S | 80±10mm | |
| | M | 95±5mm | M | 95±10mm | |
| | L | 105±5mm | L | 110±10mm | |
| | XL | 115±5mm | XL | 120±10mm | |
| | XXL | 125±5mm | / | / | |
| | Length | | | | |
| Dimensions<br>(ASTM D6319-19) | XS | 230mm min | XS | 230mm min | |
| | S | 230mm min | S | 230mm min | |
| | M | 230mm min | M | 230mm min | |
| | L | 230mm min | L | 230mm min | |
| | XL | 230mm min | XL | 230mm min | |
| | XXL | 230mm min | / | / | |
| | Thickness | | | | |
| | Palm | 0.05mm min | Palm | 0.08-0.10 mm | |
| | Finger | 0.05mm min | Finger | 0.10-0.12 mm | |
| | Before Aging | | | | |
| Physical<br>Properties<br>(ASTM D6319-19 and<br>ASTM D412-16) | Tensile Strength | 14MPa min | Tensile Strength | 14MPa min | Same |
| | Ultimate<br>Elongation | 500% min | Ultimate<br>Elongation | 500% min | |
| | | | | | |
| | After Aging | | | | |
| | Tensile Strength | 14MPa min | Tensile Strength | 14MPa min | |
| | Ultimate<br>Elongation | 400% min | Ultimate<br>Elongation | 400% min | |
| | | | | | |
| Power<br>free<br>residue<br>(ASTM D6319-19 and<br>ASTM D6124-17) | Less than 2mg per glove | | Less than 2mg per glove | | Same |
| | | | | | |
| | | | | | |
| Freedom<br>from<br>Holes<br>(ASTM D5151-19) | Meet AQL 2.5 with G1 | | Meet AQL 1.5 with G1 | | Different |
| | | | | | |
| Biocompatibility | | | | | |
| Sensitization | Under the conditions of study, not<br>a sensitizer | | Under the conditions of study, not a<br>sensitizer | | Different |
| Intracutaneous<br>Reactivity | Under the conditions of study, not<br>an irritant | | Under the conditions of study, not<br>an irritant | | |
| System Toxicity | Under the conditions of study,<br>non-system toxicity | | Not tested | | |
| In Vitro Cytotoxicity | Not tested | | Under the conditions of study, | | |
| | | | non-system toxicity | | |
| | | | | | |

Different - Color

The proposed device is provided in two colors, blue and black, and the predicate device is provided

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in three colors, blue, black and indigo. The color of the proposed device can be covered by the predicate device.

#### Different - Size & Dimensions

The size and dimension of the proposed device is not exactly same as the predicate device. The user can select appropriate model depended on size of user's hand.

#### Different - Freedom from Holes

The freedom from holes of the proposed device is different from predicate device. The proposed device meets AQL 2.5 with G1, while the predicate device meets AQL 1.5 with G1.

#### Different - Biocompatibility

The biocompatibility test item of the proposed device is different from the predicate device. The proposed device was conducted for systemic toxicity and not for cytotoxicity. While the predicate device was conducted for cytotoxicity and not for systemic toxicity.

- 7. Summary of Non-Clinical Test
Non-clinical tests were conducted to verify that the proposed device met all design specifications as was same/similar to the predicate device. The test results demonstrated that the Nitrile Exam Gloves (Blue, Black) complies with the following standards:

- > ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application
- > ASTM D5151-19 Standard Test Method for Detection of Holes in Medical Gloves
- > ASTM D3767-03 (2020) Standard Practice for Rubber-Measurement of Dimensions
- > ASTM D412-16 Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers-Tension
- > ASTM D6124-06 (Reapproved 2017) Standard Test Method for Residual Powder on Medical Gloves
- > ISO 10993-10:2010 Biological Evaluation of Medical Devices-Part 10: Tests for Irritation and Skin Sensitization:
- > ISO 10993-11:2017 Biological evaluation of medical devices-Part 11: Tests for systemic

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toxicity;

| Name of the Test<br>Methodology/<br>Standard | Purpose | Acceptance Criteria | Results |
|--------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------|
| ASTM D5151-19<br>Standard Test<br>Method for<br>Detection of Holes in<br>Medical Gloves | The test was<br>performed in<br>accordance with<br>ASTM D5151-19<br>Standard Test<br>Method for<br>Detection of Holes in<br>Medical Gloves to<br>evaluate the<br>detection of holes in<br>medical gloves. | Gloves are free from water droplets,<br>stream, or other types of water<br>leakage. | Requirement<br>met |
| ASTM D3767-03<br>(2020) Standard<br>Practice for Rubber –<br>Measurement of<br>Dimensions | The test was<br>performed in<br>accordance with<br>ASTM D3767-03<br>(2020) Standard<br>Practice for Rubber –<br>Measurement of<br>Dimensions to<br>evaluate the<br>geometrical<br>dimension of rubber<br>products and<br>specimens for<br>physical tests. | The measurement results shall<br>conform to the minimum values<br>specified in the table below. | Requirement<br>met |
| Width | | | |
| | | XS<br>75±5mm | |
| | | S<br>85±5mm | |
| | | M<br>95±5mm | |
| | | L<br>105±5mm | |
| | | XL<br>115±5mm | |
| | | XXL<br>125±5mm | |
| | | Length<br>230mm min | |
| | | Thickness | |
| | | Palm<br>0.05mm min | |
| | | Finger<br>0.05mm min | |
| ASTM D412-16<br>Standard Test<br>Methods for<br>Vulcanized Rubber<br>and Thermoplastic<br>Elastomers—Tension | The test was<br>performed in<br>accordance with<br>ASTM D412-16<br>Standard Test<br>Methods for<br>Vulcanized Rubber<br>and Thermoplastic<br>Elastomers—Tension<br>to evaluate the | The measurement results shall<br>conform to the minimum values<br>specified in the table below<br>Before Aging:<br>Tensile<br>Strength<br>14MPa min<br>Ultimate<br>Elongation<br>500% min<br>After Aging: | Requirement<br>met |
| | tensile (tension)<br>properties<br>of<br>vulcanized thermoset<br>rubbers and<br>thermoplastic<br>elastomers. | Tensile<br>Strength | 14MPa min |
| | | Ultimate<br>Elongation | 400% min |
| ASTM D6124-06<br>Standard Test<br>Method for Residual<br>Powder on Medical<br>Gloves | The test was<br>performed in<br>accordance with<br>ASTM D6124-06<br>Standard Test<br>Method for Residual<br>Powder on Medical<br>Gloves to evaluate<br>the amount of<br>residual powder (or<br>filter- retained mass)<br>found on medical<br>gloves. | Less than 2mg per glove | Requirement<br>met |

Table 2 Summary of Performance Testing

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## Table 3 Summary of Biocompatibility Testing

| Test Methodology | Purpose | Acceptance Criteria | Result |
|------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|---------------------------------------------------------------------------------------------------|
| System Toxicity | The<br>test<br>was<br>performed<br>in<br>accordance with ISO<br>10993-11<br>Biological<br>evaluation of medical<br>devices - Part 11:<br>Tests for systemic<br>toxicity to evaluate the<br>systemic toxicity of<br>the test sample. | Non-system toxicity | Under the conditions<br>of<br>the<br>study,<br>the<br>proposed device was<br>non-system toxicity. |
| Sensitization | The<br>test<br>was<br>performed<br>in<br>accordance with ISO<br>10993-10<br>Third<br>Edition<br>2010-08-01<br>Biological evaluation<br>of medical devices -<br>Part 10:<br>Tests for<br>irritation<br>and<br>skin<br>sensitization<br>to<br>evaluate<br>the | Non-sensitizing | Under the conditions<br>of<br>the<br>study,<br>the<br>proposed device was<br>non-sensitizing. |

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| | sensitization of the test sample. | | |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|----------------------------------------------------------------------------|
| Intracutaneous<br>Reactivity | The test was performed in accordance with ISO 10993-10 Third Edition 2010-08-01 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization to evaluate the irritation of the test sample. | Non-irritating | Under the conditions of the study, the proposed device was non-irritating. |

#### 8. Clinical Test Conclusion

No clinical study is included in this submission.

#### 9. Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the proposed subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device K211457.