K Number

Device Name

LYDUS Nitrile Examination Gloves, Powder Free

Manufacturer

Nathan Trading Co., Ltd

Date Cleared

2021-02-12

(108 days)

Product Code

LZA

Regulation Number

880.6250

Intended Use

LYDUS Nitrile Examination Gloves, Powder Free is a disposable device intended for medical purposes that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner.

Device Description

The subject device in this 510(k) Notification is LYDUS Nitrile Examination Gloves, Powder Free. The subject device is a patient examination glove made from nitrile compound, blue color, powder free and non-sterile (Per 21 CFR 880.6250, Class I). The device meets the specifications in ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application.

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

K192333

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

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

Therapeutic

No.
The device is an examination glove intended to prevent contamination, not to treat a condition or disease.

Diagnostic

No.
The device is an examination glove, used to prevent contamination, not to diagnose medical conditions or provide diagnostic information.

SaMD (Software as a Medical Device)

The device is a physical glove made of nitrile, not a software application. The description explicitly details its material and physical characteristics.

IVD (In Vitro Diagnostic)

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

Here's why:

Definition of IVD: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions. They are used to diagnose, monitor, or screen for diseases.
Intended Use: The intended use of the LYDUS Nitrile Examination Gloves is to be worn on the hand or fingers to prevent contamination between patient and examiner. This is a barrier device, not a diagnostic test performed on a sample.
Device Description: The device is described as a patient examination glove made from nitrile. This aligns with its function as a barrier, not a diagnostic tool.
Lack of Diagnostic Elements: The description does not mention any components or processes related to analyzing biological samples or providing diagnostic information.

The device is clearly described as a medical device (specifically a Class I examination glove), but its function is protective and preventative, not diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes

LZA

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Hand or fingers

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Examiner / Not Specified

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 testing was performed based on ASTM D6319-19 for Physical Dimensions, Physical Requirements, Detection of Holes, and Residual Powder. Biocompatibility testing was performed based on ISO 10993-10 for skin irritation and sensitization, ISO 10993-5 for in vitro cytotoxicity, and ISO 10993-11 for acute systemic toxicity. All tests passed their respective acceptance criteria.

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

Physical Dimensions Test:
- Width: 91 mm (Mean) (for medium size)
- Length: 241 mm (Mean) (for medium size)
- Thickness: Finger - 0.13 mm (Mean), Palm - 0.09 mm (Mean)
Physical Requirements Test:
- Before Acceleration Aging: Tensile Strength (MPa): 34 (Mean), Ultimate Elongation (%): 601 (Mean)
- After Acceleration Aging: Tensile Strength (MPa): 34 (Mean), Ultimate Elongation (%): 571
Freedom from Holes (Water Tight -1000 ml) - ASTM D6319-19 (Cross Reference D5151): AQL 2.5
Residual Powder (ASTM D6124-11): 0.80 mg/glove

Predicate Device(s)

K192333

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 logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized symbol. To the right is the FDA logo, with the letters 'FDA' in a blue square, followed by 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.

February 22, 2021

Nathan Trading Co., Ltd % Abdel Halim, PharmD, MSc, PhD, DABCC President Global Quality and Regulatory Services 10 Scenic Way Monroe, New Jersey 08831

Re: K203191

Trade/Device Name: LYDUS Nitrile Examination Gloves, Powder Free Regulation Number: 21 CFR 880.6250 Regulation Name: Non-powdered patient examination glove Regulatory Class: Class I, reserved Product Code: LZA

Dear Abdel Halim:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated February 12, 2021. Specifically, FDA is updating this SE Letter as an administrative correct an incorrect contact name and an incorrect 510(k) number and contact name in the header.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Ryan Ortega, OHT4: Office of Surgical and Infection Control Devices, 240-402-2303, Ryan.Ortega@fda.hhs.gov.

Sincerely,

Ryan Ortega -S

Ryan Ortega, PhD 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

Image /page/1/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that 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.

February 12, 2021

Nathan Trading Co., Ltd % Abdel B. Halim, PharmD, MSc, PhD, DABCC Responsible Third-Party Official Global Quality and Regulatory Services 10 Scenic Way Monroe, NJ 08831

Re: K203191

Trade/Device Name: LYDUS Nitrile Examination Gloves, Powder Free Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LZA Dated: January 26, 2021 Received: January 28, 2021

Dear Rafael Aguila:

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 (OS) 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Ryan Ortega -S

For CAPT. Elizabeth Claverie, M.S. Assistant Director 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)

K203191

Device Name

LYDUS Nitrile Examination Gloves, Powder Free

Indications for Use (Describe)

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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Image /page/4/Picture/0 description: The image is a circular logo for Nathan Trading Company Limited, or NTC. The logo has a green border with the word "NATHAN" at the top and "TRADING COMPANY LIMITED" at the bottom. There are two stars on either side of the word "NATHAN". In the center of the logo is the acronym "NTC" in bold, black letters.

NATHAN TRADING CO., LTD 58 Moo 12 Palan Sub-District, Nathan District, Ubon Ratchathani 34170 Thailand E-mail: csaiyasak@nathantrad.comTel.: +66818789953 Web: www.nathantrad.com

510(K) Summary K203191

LYDUS NITRILE EXAMINATION GLOVES, POWDER FREE

Preparation Date: February 9, 2021

1. SUBMITTER

Company Name: Nathan Trading Co., Ltd. Company Address: 58 Moo 12 Palan Sub-District, Nathan District, Ubon Ratchathani 34170 Thailand

Contact Person: Prof. Dr. Chansamone Saiyasak Telephone Number: +66-81-878-9953 Email: csaiyasak@nathantrad.com

2. NAME OF THE DEVICE

Trade Name / Proprietary Name: LYDUS Nitrile Examination Gloves, Powder Free Device Name: LYDUS Nitrile Examination Gloves, Powder Free Device Classification Name: Patient Examination Gloves Device Class: Class I Device Classification Number: 21 CFR 880.6250 Product Code: LZA

3. IDENTIFICATION OF THE LEGALLY MARKETED DEVICE

Predicate Device: K192333 Device Name: Blue Nitrile Examination Gloves Powder Free Device Classification Name: Patient Examination Gloves Device Classification Number: 21 CFR 880.6250 Device Class: Class I Product Code: LZA Review Panel: General Hospital

4. DEVICE DESCRIPTION

5. INTENDED USE OF THE DEVICE

L YDUS Nitrile Examination Gloves, Powder Free is a disposable device intended for medical purposes that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner.

6. TECHNOLOGICAL CHARACTERISTIC COMPARISON FOR THE PROPOSED AND PREDICATE DEVICES

		DEVICE PERFORMANCE
CHARACTERISTICS	PREDICATE	SUBJECT	REMARKS
510(k) Number	K192333	K203191	-
Device Name	Blue Nitrile
Examination Gloves
Powder Free	Nitrile Examination
Gloves, Powder Free	-
Product Code	LZA	LZA	Same
Intended Use	JR MEDIC Blue Nitrile
Examination Gloves
Powder Free is
disposable devices
intended for medical
purpose that are worn
on the examiner's
hand or fingers to
prevent contamination
between patient and
examiner. The device is
for over the-counter use.	LYDUS Nitrile
Examination Gloves,
Powder Free is a
disposable device
intended for medical
purposes that is worn
on the examiner's hand
or fingers to prevent
contamination between
patient and examiner.	Same
Materials of Use
(ASTM
D6910/D6910M-19)	Nitrile compound	Nitrile compound	Same
Color	Blue	Blue	Same
Texture	Finger Textured	Finger Textured	Same
Size
(ASTM D6319-19)	Small, Medium, Large,
Extra Large	Small, Medium, Large,
Extra Large	Same
Sterilization	Non-sterile	Non-sterile	Same
Usage	Single usage	Single usage	Same
Dimensions
(ASTM D6319-19)	Length Min. 230 min
Width Min 95+/-10 mm
(for medium size)	Length Min. 230 min
Width Min 95+/-10 mm
(for medium size)	Same
Physical Properties
(ASTM D6319-19)	Before Aging
Tensile Strength
Min 14 Mpa
Ultimate Elongation
Min 500%	Before Aging
Tensile Strength
Min 14 Mpa
Ultimate Elongation
Min 500%	Same
	After Aging
Tensile Strength
Min 14 Mpa
Ultimate Elongation
Min 400%	After Aging
Tensile Strength
Min 14 Mpa
Ultimate Elongation
Min 400%
	Thickness
(ASTM D6319-19)	Palm min 0.05 mm
Finger min 0.05 mm		Palm min 0.05 mm
Finger min 0.05 mm	Same
	Powder Free
(ASTM D6319-19)	≤2 mg/glove		≤2 mg/glove	Same
	Freedom from Holes
(Water Tight -1000 ml) -
ASTM D6319-19 (Cross
Reference D5151)	Passed		Passed	Same
	Biocompatibility -
SKIN SENSITIZATION -
ISO 10993-10: 2010 (E)	Under the conditions of
study not an irritant		Under the conditions of
study not an irritant	Same
Biocompatibility -
SKIN IRRITATION - ISO
10993-10: 2010 (E)	Under the conditions of
the study not a sensitizer	Under the conditions of
the study not a
sensitizer	Same
Biocompatibility -
IN VITRO
CYTOTOXICITY - ISO
10993-5: 2009(E)	Under the conditions of
the cytotoxicity study,
additional acute
systemic toxicity testing
results showed no
systemic toxicity
concern.	Exhibit cytotoxic
reactivity at 100%
extract concentration
(Grade 4 with neat
extract).
Non-cytotoxic
reactivity at 50%, 25%,
12.5% and 6.25%
extract concentration.	Similar
Biocompatibility -
ACUTE SYSTEMIC
TOXICITY - ISO 10993-
11: 2017(E)	Under the conditions of
the study no systemic
toxicity	No systemic toxicity
under the experimental
conditions employed	Similar
Manufacturer(s)	JR Engineering &
Medical Technologies
(M) SDN.BHD.,
Malaysia	Nathan Trading Co.,
Ltd., Thailand

There are no significant differences between the two products and are identical in terms of intended use, materials, design, manufacturing methods. Both devices meet the ASTM standard D6319-19.

7. NON-CLINICAL TESTING SUMMARY

PERFORMANCE DATA

Test Method	Purpose	Acceptance Criteria	Result
ASMT D6319-19
Standard Specification
for Nitrile Examination
Gloves for Medical
Application - Physical
Dimensions Test	To determine the
width, length, and
thickness of the
gloves	Width:
91 mm (Mean)
(for medium size)
Length:
241 mm (Mean)(for medium size)
Thickness: Finger -
0.13 mm (Mean) Palm -
0.09 mm (Mean)	Passed
ASMT D6319-19
Standard Specification
for Nitrile Examination
Gloves for Medical
Application - Physical
Requirements Test	To determine the
tensile strength
and ultimate
elongation before
and after
acceleration aging	Before Acceleration Aging: Tensile
Strength (MPa): 34 (Mean) Ultimate
Elongation (%): 601 (Mean)
After Acceleration Aging:
Tensile Strength (MPa): 34 (Mean)
Ultimate Elongation (%): 571	Passed
ASTM D6319-19
(ASTM D5151-11)
Standard Test Method
for Detection of Holes in
Medical Gloves	To determine the
holes in the
gloves	(Mean)
AQL 2.5	Passed
ASMT D6319-19
(ASTM D6124-11)
Standard Test Method
for Residual Powder on
Medical Gloves	To determine the
residual powder
in the gloves