Nitrile Exam Gloves (Blue, Black)

• K Number: K221143
• Device Name: Nitrile Exam Gloves (Blue, Black)
• Manufacturer: Hebei Astro Medical Supply Co., Ltd.
• Date Cleared: 2022-08-25 ( 127 days)
• Product Code: LZA
• Regulation Number: 880.6250

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 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.

Predicate Devices

K211457

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device is a simple medical glove and the description focuses on physical and biological properties, not computational capabilities. There is no mention of AI, ML, or any related technologies.

Therapeutic

No
The device is described as a disposable glove intended to prevent contamination, which is a protective barrier function, not a therapeutic intervention to treat or manage a disease or condition.

Diagnostic

No

Explanation: The device is a medical glove intended to prevent contamination. It is not designed to diagnose any condition or disease.

SaMD (Software as a Medical Device)

No

The device is a physical product (nitrile gloves) and the summary describes physical and biological performance testing, not software validation or functionality.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use is "to prevent contamination between patient and examiner." This is a barrier function, not a diagnostic function.
• Device Description: The description focuses on the physical properties and standards met by the glove (ASTM D6319-19, etc.). There is no mention of any components or mechanisms for analyzing samples or providing diagnostic information.
• Lack of Diagnostic Elements: There are no mentions of image processing, AI/ML, input imaging modality, or performance metrics related to diagnostic accuracy (like sensitivity, specificity, etc.). The performance studies focus on the physical and biological properties of the glove.

IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not perform any such function.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications 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.

Product codes (comma separated list FDA assigned to the subject device)

LZA

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

hands

Indicated Patient Age Range

Not Found

Intended User / Care Setting

examiner's hands

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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 toxicity

Key results for each test:

• ASTM D5151-19: Requirement met for detection of holes.
• ASTM D3767-03 (2020): Requirement met for geometrical dimension.
• ASTM D412-16: Requirement met for tensile properties.
• ASTM D6124-06 (Reapproved 2017): Requirement met for residual powder.
• ISO 10993-11:2017 (System Toxicity): Under the conditions of the study, the proposed device was non-system toxicity.
• ISO 10993-10:2010 (Sensitization): Under the conditions of the study, the proposed device was non-sensitizing.
• ISO 10993-10:2010 (Intracutaneous Reactivity): Under the conditions of the study, the proposed device was non-irritating.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

• Freedom from Holes: Meet AQL 2.5 with G1
• Powder free residue: Less than 2mg per glove
• Tensile Strength (Before Aging): 14MPa min
• Ultimate Elongation (Before Aging): 500% min
• Tensile Strength (After Aging): 14MPa min
• Ultimate Elongation (After Aging): 400% min
• Thickness (Palm): 0.05mm min
• Thickness (Finger): 0.05mm min

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K211457

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 880.6250 Non-powdered patient examination glove.

(a)
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.(b)
Classification. 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.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol is a stylized representation of a human figure, while the FDA name is written in blue and includes the words "U.S. Food & Drug Administration".

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
Number	21 CFR 880.6250	21 CFR 880.6250	Same
Class	I	I	Same
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.	The Powder Free Nitrile
Examination Gloves is a
disposable device intended for
medical purpose that is worn on
the examiner's hands to prevent
contamination between patient
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
/Powder or
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
(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
Properties
(ASTM D6319-19 and
ASTM D412-16)	Tensile Strength	14MPa min	Tensile Strength	14MPa min	Same
	Ultimate
Elongation	500% min	Ultimate
Elongation	500% min
	After Aging
	Tensile Strength	14MPa min	Tensile Strength	14MPa min
	Ultimate
Elongation	400% min	Ultimate
Elongation	400% min
Power
free
residue
(ASTM D6319-19 and
ASTM D6124-17)	Less than 2mg per glove		Less than 2mg per glove		Same
Freedom
from
Holes
(ASTM D5151-19)	Meet AQL 2.5 with G1		Meet AQL 1.5 with G1		Different
Biocompatibility
Sensitization	Under the conditions of study, not
a sensitizer		Under the conditions of study, not a
sensitizer		Different
Intracutaneous
Reactivity	Under the conditions of study, not
an irritant		Under the conditions of study, not
an irritant
System Toxicity	Under the conditions of study,
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
Methodology/

Standard	Purpose	Acceptance Criteria	Results
ASTM D5151-19
Standard Test
Method for
Detection of Holes in
Medical Gloves	The test was
performed in
accordance with
ASTM D5151-19
Standard Test
Method for
Detection of Holes in
Medical Gloves to
evaluate the
detection of holes in
medical gloves.	Gloves are free from water droplets,
stream, or other types of water
leakage.	Requirement
met
ASTM D3767-03
(2020) Standard
Practice for Rubber –
Measurement of
Dimensions	The test was
performed in
accordance with
ASTM D3767-03
(2020) Standard
Practice for Rubber –
Measurement of
Dimensions to
evaluate the
geometrical
dimension of rubber
products and
specimens for
physical tests.	The measurement results shall
conform to the minimum values
specified in the table below.	Requirement
met
Width
		XS
75±5mm
		S
85±5mm
		M
95±5mm
		L
105±5mm
		XL
115±5mm
		XXL
125±5mm
		Length
230mm min
		Thickness
		Palm
0.05mm min
		Finger
0.05mm min
ASTM D412-16
Standard Test
Methods for
Vulcanized Rubber
and Thermoplastic
Elastomers—Tension	The test was
performed in
accordance with
ASTM D412-16
Standard Test
Methods for
Vulcanized Rubber
and Thermoplastic
Elastomers—Tension
to evaluate the	The measurement results shall
conform to the minimum values
specified in the table below
Before Aging:
Tensile
Strength
14MPa min
Ultimate
Elongation
500% min
After Aging:	Requirement
met
	tensile (tension)
properties
of
vulcanized thermoset
rubbers and
thermoplastic
elastomers.	Tensile
Strength	14MPa min
		Ultimate
Elongation	400% min
ASTM D6124-06
Standard Test
Method for Residual
Powder on Medical
Gloves	The test was
performed in
accordance with
ASTM D6124-06
Standard Test
Method for Residual
Powder on Medical
Gloves to evaluate
the amount of
residual powder (or
filter- retained mass)
found on medical
gloves.	Less than 2mg per glove	Requirement
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
test
was
performed
in
accordance with ISO
10993-11
Biological
evaluation of medical
devices - Part 11:
Tests for systemic
toxicity to evaluate the
systemic toxicity of
the test sample.	Non-system toxicity	Under the conditions
of
the
study,
the
proposed device was
non-system toxicity.
Sensitization	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	Non-sensitizing	Under the conditions
of
the
study,
the
proposed device was
non-sensitizing.

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	sensitization of the test sample.
Intracutaneous
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.