Blue Nitrile Exam Glove, Powder Free

• K Number: K210058
• Device Name: Blue Nitrile Exam Glove, Powder Free
• Manufacturer: Great Harvest Trading Co., Ltd.
• Date Cleared: 2021-03-30 ( 78 days)
• Product Code: LZA
• Regulation Number: 880.6250

Intended Use

The Blue Nitrile Exam Glove, Powder Free is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.

Device Description

The subject device is powder free nitrile examination gloves. The subject device is blue. The subject device is non-sterile.

Predicate Devices

K171422

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device is a standard examination glove and the summary contains no mention of AI or ML.

Therapeutic

No.
The device, a blue nitrile exam glove, is intended for preventing contamination, not for treating or diagnosing a disease or condition, which are characteristics of therapeutic devices.

Diagnostic

No

Explanation: The device is a non-sterile disposable glove intended to prevent contamination, not to diagnose a condition.

SaMD (Software as a Medical Device)

No

The device is a physical product (gloves) and the description focuses on material properties and physical performance, not software 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 clearly stated as a "non-sterile disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner." This describes a barrier device used for personal protection and infection control, not a device used to examine specimens derived from the human body for diagnostic purposes.
• Device Description: The description confirms it's a "powder free nitrile examination glove." This aligns with the intended use as a protective barrier.
• Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
  • Analyzing biological samples (blood, urine, tissue, etc.)
  • Detecting specific analytes or markers
  • Providing diagnostic information about a patient's health status
  • Using reagents or assays

The information provided describes a Class I medical device (general wellness/low risk) used for barrier protection, which falls under a different regulatory category than IVDs.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Blue Nitrile Exam Glove, Powder Free is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.

Product codes

LZA

Device Description

The subject device is powder free nitrile examination gloves. The subject device is blue. The subject device is non-sterile.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

hands or finger

Indicated Patient Age Range

Not Found

Intended User / Care Setting

examiner

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. The test results demonstrated that the proposed device complies with the following standards:
ISO 10993-10:2010 Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
ISO 10993-5:2009 Biological Evaluation of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity
ASTM D6124-06 (Reapproved 2017), Standard Test Method for Residual Powder on Medical Gloves
ASTM D5151-19 Standard Test Method for Detection of Holes in Medical Gloves.
ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application.

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

Table3 Performance Comparison
Colorant: Blue (Subject Device); White/ Blue/ Black/ Pink (Predicate Device)
Physical Properties: Before Aging - Tensile Strength 14MPa, min (Both); Ultimate Elongation 500% min (Both); After Aging - Tensile Strength 14MPa, min (Both); Ultimate Elongation 400%min (Both)
Comply with ASTM D6319 (Both)
Freedom from Holes: Be free from holes when tested in accordance with ASTMD5151, AQL=2.5 (Both)
Powder Content: 0.05 mg per glove (Subject Device); Meet the requirements of ASTM D6124 (Predicate Device)

Table4 Safety Comparison
Material: Nitrile (Both)
Biocompatibility: Irritation (ISO 10993-10:2010 Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization) - Under the conditions of the study, not an irritant (Subject Device); Comply with ISO10993-10 (Predicate Device)
Sensitization (ISO 10993-10:2010 Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization) - Under conditions of the study, not a sensitizer (Subject Device)
Cytotoxicity (ISO 10993-5:2009 Biological Evaluation of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity) - Under conditions of the study, device extract is not cytotoxic (Subject Device)

Predicate Device(s)

K171422

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services USA seal. To the right of the seal is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 30, 2021

Great Harvest Trading Co., Ltd. % Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM.608,No.738,Shangcheng Rd.,Pudong Shanghai, Shanghai 200120 China

Re: K210058

Trade/Device Name: Blue Nitrile Exam Glove, Powder Free Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: March 16, 2021 Received: March 22, 2021

Dear Boyle Wang:

We have reviewed vour 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 mediation-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 (DICE(@fda.hhs.gov) or phone [phone] or 301-796-7100).

Sincerely.

Jiangsong Jiang -S (Affiliate)

For Ryan Ortega, Ph D. Acting 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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510(k) Summary

K210058

This summary of 510(k) is being submitted in accordance with 21 CFR 807.92.

1.0 Submitter's Information

Great Harvest Trading Co., Ltd. Name: Xinghe Road, Dongying City 257100, Shandong, China Address: Phone Number: [phone] Contact: Chongfeng Zhao Date of Preparation: Mar.16,2021

Designated Submission Correspondent

Mr. Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Room 608, No. 738 Shangcheng Rd., Pudong,Shanghai 200120 ,China Tel: [phone] Email: [e-mail]

2.0 Device Information

Trade name: Blue Nitrile Exam Glove, Powder Free Common name: Patient Examination Gloves Classification name: Non-powdered patient examination glove Model(s): S, M. L. XL

3.0 Classification

Production code: LZA Regulation number: 21CFR880.6250 Classification: Class | Panel: General Hospital

4.0 Predicate Device Information

Manufacturer: Ever Global (Vietnam) Enterprise Corp Disposable Powder Free Nitrile Examination Glove, White/ Device: Blue/ Black/ Pink Color 510(k) number: K171422

5.0 Indication for Use

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The Blue Nitrile Exam Glove, Powder Free is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.

6.0 Device Description

The subject device is powder free nitrile examination gloves. The subject device is blue. The subject device is non-sterile.

7.0 Technological Characteristic Comparison Table

Table1-General Comparison
Item	Subject Device
(K210058)	Predicated Device
(K171422)	Remark
Product Code	LZA	LZA	Same
Regulation No.	21CFR880.6250	21CFR880.6250	Same
Class			Same
Intended Use	The Blue Nitrile
Exam Glove,
Powder Free is a
non-sterile
disposable device
intended for
medical purposes
that is worn on the
examiner's hands
or finger to prevent
contamination
between patient
and examiner.	The Disposable
Powder Free Nitrile
Examination Glove,
White/ Blue/ Black/
Pink Color is a
disposable device
intended for
medical purposes
that is worn on the
examiner's hands
to prevent
contamination
between patient
and examiner.	Same
Powdered or
Powered free	Powdered free	Powdered free	Same
Design Feature	Ambidextrous	Ambidextrous	Same
Labeling Information	Single-use
indication, powder
free, device color,
device name, glove
size and quantity,
Nitrile Glove
Powder Free Blue,	Single-use
indication, powder
free, device color,
device name, glove
size and quantity,
Disposable Powder
Free Nitrile
Examination Glove	Same

Table1-General Comparison

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	Non-Sterile	Non-Sterile
--	-------------	-------------	--

| Predicate

Device(K171422)	Designation	Size					Tolerance
		XS	S	M	L	XL
	Length, mm	230	230	230	230	230	min
	Width, mm	75	85	95	105	115	$\pm 5$
	Thickness, mm
	Finger	0.05					min
	Palm	0.05					min
Subject Device
(K210058)	Designation	Size					Tolerance
		S	M	L	XL
	Length, mm	230	230	230	230		$\pm 10$
	Width, mm	80	95	110	120		$\pm 10$
	Thickness, mm:
	Finger	0.08					$\pm 0.03$
	Palm	0.08					$\pm 0.03$
Remark	Similar

Table2 Device Dimensions Comparison

Analysis: The physical dimensions are different with that of the predicate, but they all meet the requirements of ASTM D6319-19,so the differences do not raise any new safety or performance questions.

Table3 Performance Comparison

| Item | Subject device
(K210058) | Predicated
device
(K171422) | Remark | | |
|------------------------|---------------------------------------------------------------|---------------------------------------------------------------|------------|------------|------|
| Colorant | Blue | White/ Blue/
Black/ Pink | Same | | |
| Physical
Properties | Before
Aging | Tensile
Strength | 14MPa, min | 14MPa, min | Same |
| | | Ultimate
Elongation | 500% min | 500% min | Same |
| | After
Aging | Tensile
Strength | 14MPa, min | 14MPa, min | Same |
| | | Ultimate
Elongation | 400%min | 400%min | Same |
| | Comply with ASTM D6319 | Comply with ASTM D6319 | Same | | |
| Freedom from Holes | Be free from
holes when
tested in
accordance
with | Be free from
holes when
tested in
accordance
with | Same | | |

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	ASTMD5151	ASTMD5151
	AQL=2.5	AQL=2.5
Powder Content	0.05 mg per
glove	Meet the
requirements of
ASTM D6124	Same

| Item | | Subject
device
(K210058) | Predicated
device
(K171422) | Remark |
|------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------|---------|
| Material | | Nitrile | Nitrile | Same |
| Biocompatibility | Irritation (ISO
10993-10:2010
Biological
Evaluation of
Medical Devices -
Part 10: Tests For
Irritation And Skin
Sensitization) | Under the
conditions of
the study, not
an irritant | Comply with
ISO10993-
10 | Same |
| | Sensitization
(ISO 10993-
10:2010
Biological
Evaluation of
Medical Devices -
Part 10: Tests For
Irritation And Skin
Sensitization)
Cytotoxicity (ISO
10993-5:2009
Biological
Evaluation of
Medical Devices -
Part 5: Tests For
In Vitro
Cytotoxicity) | Under
conditions of
the study, not
a sensitizer.
Under
conditions of
the study,
device
extract is not
cytotoxic | / | Similar |

Table4 Safety Comparison

8.0 Discussion of Non-clinical and Performance Testing

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:

ISO 10993-10:2010 Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.

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ISO 10993-5:2009 Biological Evaluation of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity

ASTM D6124-06 (Reapproved 2017), Standard Test Method for Residual Powder on Medical Gloves

ASTM D5151-19 Standard Test Method for Detection of Holes in Medical Gloves.

ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application.

9.0 Discussion of Clinical and Performance Testing

Clinical testing is not needed for this device.

10.0 Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the subject device Blue Nitrile Exam Glove, Powder Free is as safe, as effective, and performs as well as or better than the legally marketed predicated device Disposable Powder Free Nitrile Examination Glove cleared under K171422.