K Number

Device Name

Edma Synthetic Nitrile Examination Gloves

Manufacturer

Edma Group, LLC

Date Cleared

2021-08-09

(82 days)

Product Code

LZA

Regulation Number

880.6250

Intended Use

A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner.

Device Description

The subject device is powder free synthetic Nitrile patient examination gloves. The subject device is blue. The design of subject device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D6319. The subject device is non-sterile.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K172015

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical and material properties of examination gloves, with no mention of AI or ML.

Therapeutic

No
The device, a patient examination glove, is intended to prevent contamination, not to provide therapy or treatment for a specific condition or disease.

Diagnostic

Explanation: The device is a patient examination glove used to prevent contamination, not to diagnose a medical condition. Its function is to provide a barrier between the patient and the examiner.

SaMD (Software as a Medical Device)

The device description and performance studies clearly indicate the device is a physical glove made of nitrile, not software.

IVD (In Vitro Diagnostic)

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

Here's why:

Definition of IVD: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. They are used outside of the body.
Intended Use of this device: The intended use of this device is to be worn on the hands or fingers of an examiner to prevent contamination between the patient and the examiner. This is a barrier device used during a physical examination or procedure.
Device Description: The description focuses on the physical properties and standards related to a glove, not on analyzing biological samples.

The information provided clearly indicates this is a medical device used for protection and hygiene during patient interaction, not for analyzing biological samples in a laboratory setting.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner.

Product codes

LZA

Device Description

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 subject device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The subject device were evaluated according to the following standards: ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application; ASTM D6124-06 (Reapproved 2017), Standard Test Method for Residual Powder on Medical Gloves; ASTMD5151-19, Standard Test Method for Detection of Holes in Medical Gloves.
The biocompatibility evaluation for the subject device were evaluated according to the following standard: ISO 10993-5:2009 Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity; ISO 10993-10:2010 Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
Biocompatibility testing including cytotoxicity test, sensitization test and irritation test according to ISO 10993-1 standards, have been conducted on the Edma Synthetic Nitrile Examination Gloves.
Under the parameters of the tests it is concluded that they are biocompatible, and that there are no new issues of biocompatibility regarding their use as intended.

Key results:

ASTM D6319 Physical Dimensions Test: Length: >230, Width: M: 96-99, L: 106-109, XL: 114-118 (Pass); Thickness (mm): Finger: 0.08-0.13, Palm: 0.08-0.09 (Pass).
ASTM D5151 Watertightness Test for Detection of Holes: 0/125 leaks (Pass).
ASTM D6124 Powder Content: 0.07 mg (Pass).
ASTM D412 Physical properties: Before Tensile Aging Strength 15-18.5 (Pass); Ultimate Elongation 506-576 (Pass); After Aging Tensile Strength 14-17.6 (Pass); Ultimate Elongation 400-522 (Pass).
ISO 10993-5 Cytotoxicity: Did not show potential toxicity to L-929 cells (Pass).
ISO 10993-10 Irritation: Not an irritant (Pass).
ISO 10993-10 Sensitization: Not a sensitizer (Pass).

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

Not Found

Predicate Device(s)

K172015

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

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

August 9, 2021

Edma Group, LLC % Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM. 1801, No. 161, Lujiazui East Rd., Pudong Shanghai, 200120 China

Re: K211540

Trade/Device Name: Edma Synthetic 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: May 12, 2021 Received: May 19, 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.

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. 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

Indications for Use

510(k) Number (if known) K211540

Device Name

Edma Synthetic Nitrile Examination Gloves

Indications for Use (Describe)

A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or finger 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 (K211540)

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

1.0 Submitter's Information

Edma Group, LLC. Name: Address: 3634 E Piccadilly Rd, Phoenix, AZ 85018. Contact: Mr. Vio Cretu Date of Preparation: 07/03/2021

Designated Submission Correspondent

Mr. Boyle Wanq Shanghai Truthful Information Technology Co., Ltd. Room 1801, No. 161 Lujiazui East Rd., Pudong Shanghai, 200120 China Tel: +86-21-50313932 Email: Info@truthful.com.cn

2.0 Device Information

Trade name: Edma Synthetic Nitrile Examination Gloves Common name: Patient Examination Glove Classification name: Non-powdered patient examination glove Model(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: Careglove Global Sdn Bhd Device: Powder Free Nitrile Examination Gloves, Blue (colored) 510(k) number: K172015

5.0 Indication for Use

A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner.

6.0 Device Description

Item	Subject device	Predicate device	Comparison
510(k) number	K211540	K172015	--
Product Code	LZA	LZA	Same
Regulation No.	21CFR880.6250	21CFR880.6250	Same
Class	I	I	Same
Intended Use	A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner.	A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hand or finger to prevent contamination between patient and examiner.	Same
Powdered or
Powered free	Powdered free	Powdered free	Same
Main Material	Nitrile	Nitrile	Same
Colorant	Blue	Blue	Same
Design Feature	Ambidextrous	Ambidextrous	Same
Single Use	Yes	Yes	Same
Sterility status	Non-Sterile	Non-Sterile	Same
Dimensions(mm)	Length:≥230;
Width:
M:95±10;
L:110±10;
XL:120±10;	Length:
XS/S:≥220;
M/L/XL: ≥230;
Width:
XS:70±10;
S:80±10;
M:95±10;
L:110±10;
XL:120±10;	Similar
Physical	Before Tensile 14MPa min	Tensile 14MPa min	Same

7.0 Technological Characteristic Comparison Table

Properties	Aging	Strength
		Ultimate
Elongation	500%min	Ultimate
Elongation	500%min	Same
	After
Aging	Tensile
Strength	14MPa,min	Tensile
Strength	14MPa,min	Same
		Ultimate
Elongation	400%min	Ultimate
Elongation	400%min	Same
Freedom
from
Holes		Be free from holes when
tested in accordance
with ASTM		Meet AQL 1.5
Meet AQL 2.5		Same
		AQL=2.5	D5151
Powder Content		230
Width:
M: 96-99
L: 106-109
XL: 114-118
Pass
		Thickness (mm):
Finger: ≥0.08
Palm: ≥0.08	Finger: 0.08-0.13
Palm: 0.08-0.09
Pass
ASTM D5151	Watertightness
Test for
Detection of
Holes	Meet the requirements of ASTM D5151 AQL 2.5	0/125 leaks
Pass
ASTM D6124	Powder Content	Meet the requirements of ASTM D6124