Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device is a disposable medical examination glove, and the summary focuses on physical and biological performance characteristics, with no mention of AI or ML.

Therapeutic

No
The device, a disposable nitrile medical examination glove, is intended for contamination prevention and examination purposes, not for treating or preventing disease or injury.

Diagnostic

No

The device description indicates that it is a "Disposable Nitrile Medical Examination Glove," which is used to prevent contamination, not to diagnose a medical condition.

SaMD (Software as a Medical Device)

No

The device is a physical medical device (gloves) and does not involve any software component.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections. These tests are performed outside the body (in vitro).
Device Description and Intended Use: The description clearly states the device is a "Disposable Nitrile Medical Examination Glove" intended to be "worn on the examiner's hands to prevent contamination between patient and examiner." This is a barrier device used for protection and hygiene, not for performing diagnostic tests on patient samples.

The information provided focuses on the physical properties and biocompatibility of the glove, which are relevant for a medical device worn on the skin, but not for an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Disposable Nitrile Medical Examination Glove is a disposable device intended for medical purposes 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 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

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 results:

Physical Dimensions Test (ASTM D6319):
Lot1: Length: >230; Width: XS: 78-80; S: 85-86; M: 95-96; L: 105-106; XL: 115-116; Finger Thickness: 0.11-0.13; Palm Thickness: 0.06-0.07. Pass.
Lot2: Length: >230; Width: XS: 79-80; S: 85-86; M: 95-96; L: 105-106; XL: 115-116; Finger Thickness: 0.11-0.13; Palm Thickness: 0.06-0.07. Pass.
Lot3: Length: >230; Width: XS: 78-80; S: 85-86; M: 95-96; L: 105-106; XL: 115-116; Finger Thickness: 0.11-0.13; Palm Thickness: 0.07. Pass.

Watertightness Test for Detection of Holes (ASTM D5151):
Lot1: 0/125 leaks. Pass.
Lot2: 0/125 leaks. Pass.
Lot3: 0/125 leaks. Pass.

Powder Content (ASTM D6124):
Lot1: 0.09mg/glove. Pass.
Lot2: 0.06mg/glove. Pass.
Lot3: 0.08mg/glove. Pass.

Physical properties (ASTM D412):
Before Aging:
Tensile Strength: Lot 1: 28-36; Lot2: 28-33; Lot3: 23-33. Pass.
Ultimate Elongation: Lot1: 510-570; Lot 2: 480-565; Lot3: 515-566. Pass.
After Aging:
Tensile Strength: Lot 1: 27-33; Lot2: 28-33; Lot3: 28-32. Pass.
Ultimate Elongation: Lot1: 485-535; Lot 2: 480-530; Lot3: 485-533. Pass.

Cytotoxicity (ISO 10993-5):
Under conditions of the study, did not show potential toxicity to L-929 cells. Pass.

Irritation (ISO 10993-10):
Under the conditions of the study, not an irritant. Pass.

Sensitization (ISO 10993-10):
Under conditions of the study, not a sensitizer. Pass.

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

Not Found

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.

K171422

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 of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

July 30, 2021

Jiangsu Cureguard Glove Co., Ltd. % Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM.608, No.738, Shangcheng Rd., Pudong Shanghai, Shanghai 200120 China

Re: K210691

Trade/Device Name: Disposable Nitrile Medical Examination Glove Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: June 15, 2021 Received: June 22, 2021

Dear Boyle Wang:

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.

1

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 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 (1-800-638-2041 or 301-796-7100).

Sincerely.

For 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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Indications for Use

510(k) Number (if known) K210691

Device Name Disposable Nitrile Medical Examination Glove

Indications for Use (Describe)

The Disposable Nitrile Medical Examination Glove is a disposable device intended for medical purposes 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 (K210691)

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

1.0 Submitter's Information

Name: Jiangsu Cureguard Glove Co., Ltd. Address: No.65 Shenzhen Road, The Economic Development Zone, Sugian , Jiangsu, 223800 China. Phone Number: +86-13485097856 Contact: Guo Hua Date of Preparation: Jun.30,2021

Designated Submission Correspondent

Mr. Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Room 608, No. 738 Shangcheng Rd., Pudong,Shanghai 200120 ,China Tel: +86-21-50313932 Email: Info@truthful.com.cn

2.0 Device Information

Trade name: Disposable Nitrile Medical Examination Glove Common name: Patient Examination Gloves Classification name: Non-powdered patient examination glove Model(s): XS,S, M, L, XL

3.0 Classification

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

4.0 Predicate Device Information

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

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5.0 Indication for Use

The Disposable Nitrile Medical Examination Glove is a disposable device intended for medical purposes that is worn on the examiner's hands 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.

| Item | Subject Device
(K210691) | Predicated Device
(K171422) |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Item | LZA | LZA |
| Regulation No. | 21CFR880.6250 | 21CFR880.6250 |
| Class | I | I |
| Intended Use | Disposable Nitrile Medical
Examination Glove is a
disposable device intended
for medical purposes that is
worn on the examiner's
hands 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. |
| Material | Nitrile | Nitrile |
| Powdered or
Powered free | Powdered free | Powdered free |
| Design Feature | Ambidextrous | Ambidextrous |
| Colorant | Blue | White/ Blue/ Black/ Pink |
| Labeling Information | Single-use
indication,
powder free, device color,
device name, glove size and
quantity,
Non-Sterile | Single-use indication, powder
free, device color, device
name, glove size and quantity,
Non-Sterile |
| Dimensions(mm) | Length:
XS/S: $\geq$ 220;
M/L/XL: $\geq$ 230;
Width:
XS: 70 $\pm$ 10;
S: 80 $\pm$ 10; | Length: $\geq$ 230;
Width:
XS: 75 $\pm$ 5;
S: 85 $\pm$ 5;
M: 95 $\pm$ 5;
L: 105 $\pm$ 5; |

7.0 Technological Characteristic Comparison Table

5

	M: 95±10;		XL: 115±5
	L: 110±10;
	XL: 120±10
Thickness(mm)	Finger: ≥0.05;		Finger: ≥0.05;
	Palm: ≥0.05		Palm: ≥0.05
Physical
Properties	Before
Aging	Tensile
Strength	14MPa, min	Tensile
Strength	14MPa, min
		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
	Freedom from
Holes	Be free from holes when
tested in accordance with
ASTMD5151 AQL=2.5		Be free from holes when tested
in accordance with
ASTMD5151 AQL=2.5
		Powder Content		Meet the requirements of
ASTM D6124
Biocompatibility		ISO 10993-10;
Under the conditions of the
study, not an irritant or a
sensitizer
ISO 10993-5
Under conditions of the
study, device extract is not
cytotoxic		Comply with
ISO 10993-10

Comply with ISO 10993-5 | |

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.

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.

6

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

| Test

Methodology	Purpose	Acceptance Criteria	Results
ASTM D6319	Physical
Dimensions
Test	Length(mm):
XS/S:≥220;
M/L/XL: ≥230;	Lot1:
Length: >230
		Width(mm):
XS: 70±10;
S: 80±10;
M: 95±10;
L: 110±10;
XL: 120±10	Width:
XS: 78-80;
S: 85-86
M: 95-96
L: 105-106
XL: 115-116
			Lot2:
Length: >230
Width:
XS: 79-80
S: 85-86
M: 95-96
L: 105-106
XL: 115-116
Lot3:
Length: >230
Width:
XS: 78-80
S: 85-86
M: 95-96
L: 105-106
XL: 115-116
Pass
		Thickness (mm) :
Finger: ≥0.05
Palm: ≥0.05	Lot1:
Finger: 0.11-0.13
Palm: 0.06-0.07
Lot2:
Finger: 0.11-0.13
Palm: 0.06-0.07
Lot3:

Table 2: Performance Characteristic Comparison

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| | | | | Finger: 0.11-0.13
Palm: 0.07
Pass | |
|------------|--------------------------------------------|---------------------------------------------|---------------------|------------------------------------------------------------------------------------|-------------------------------------------------------------------|
| ASTM D5151 | Watertightness Test for Detection of Holes | Meet the requirements of ASTM D5151 AQL 2.5 | | Lot1:
0/125 leaks
Lot2:
0/125 leaks
Lot3:
0/125 leaks
Pass | |
| ASTM D6124 | Powder Content | Meet the requirements of ASTM D6124