Predicate Devices

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 technology.

Therapeutic

No.
The device, Blue Nitrile Examination Gloves, is described as a disposable device intended for medical purposes worn on the examiner's hand to prevent contamination and is classified as a Class I patient examination glove. It does not exert any therapeutic effect on the patient.

Diagnostic

No
The device is described as an examination glove intended to prevent contamination, not to diagnose a medical condition.

SaMD (Software as a Medical Device)

No

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

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 clearly states the device is "worn on the examiner's hand to prevent contamination between patient and examiner." This is a barrier function for infection control, not a diagnostic test performed on a sample from the body.
Device Description: The description identifies the device as "Class I patient examination gloves." Examination gloves are a common medical device for protection, not for in vitro diagnostic testing.
Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information.

IVD devices are designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This device does not fit that description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Blue Nitrile Examination Gloves Powder Free is disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

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

LZA

Device Description

JR MEDIC Blue Nitrile Examination Gloves Powder Free are Class I patient examination gloves bearing the product code Nitrile - LZA (21CFR880.6250). The gloves are made from acrylonitrile-butadiene copolymer dispersion. These gloves are blue in color and are powder free.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

hand

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Examiner (medical purpose)

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 Summary:

ASTM D6319-10 (Reapproved 2015) Standard Specification for Nitrile Examination Gloves for Medical Application:
- Purpose: To determine the length of the gloves.
- Acceptance Criteria: Min 230 mm for all sizes.
- Result: X-Small:-404 mm, Small:-404 mm, Medium:-405 mm, Large:-404 mm, X-Large:-404 mm.
- Purpose: To determine the width of the gloves.
- Acceptance Criteria: X-small:- 70+/-10 mm, Small:-80+/-10 mm, Medium:-95+/-10 mm, Large:-110+/-10 mm, X-Large:-120+/-10 mm.
- Result: X-small:-74 mm, Small:-84 mm, Medium:-94 mm, Large:-105 mm, X-Large:-115 mm.
- Purpose: To determine the thickness of the gloves.
- Acceptance Criteria: Palm 0.05 mm min, Finger 0.05 mm min for all sizes.
- Result: X-Small (Palm 0.20mm, Finger 0.22mm), Small (Palm 0.19mm, Finger 0.21mm), Medium (Palm 0.20mm, Finger 0.22mm), Large (Palm 0.20mm, Finger 0.21mm), X-Large (Palm 0.20mm, Finger 0.22mm).
- Purpose: To Determine the physical properties - Tensile strength.
- Acceptance Criteria: Before Ageing Tensile Strength 14Mpa Min for all sizes; After Ageing Tensile Strength 14Mpa Min for all sizes.
- Result: Before ageing (X-Small 22.0Mpa, Small 23.0Mpa, Medium 25.6Mpa, Large 24.0Mpa, X-Large 24.5Mpa); After ageing (X-Small 18.5Mpa, Small 20.5Mpa, Medium 22.0 Mpa, Large 21.0Mpa, X-Large 21.7Mpa).
- Purpose: To Determine the physical properties - Ultimate Elongation.
- Acceptance Criteria: Before Ageing Ultimate Elongation 500% Min for all sizes; After Ageing Ultimate Elongation 400% Min for all sizes.
- Result: Before ageing (X-Small 898%, Small 896%, Medium 868%, Large 899%, X-Large 874%); After ageing (X-Small 872%, Small 861%, Medium 828%, Large 869%, X-Large 853%).
ASTM D5151-06 (Reapproved 2015) Standard Test Method for Detection of Holes in Medical Gloves:
- Purpose: To determine the holes in the gloves.
- Acceptance Criteria: AQL 2.5.
- Result: Gloves Passes AQL 1.5.
ASTM D6124-06 (Reapproved 2017) Standard Test Method for Residual Powder on Medical Gloves:
- Purpose: To determine the residual powder in the gloves.
- Acceptance Criteria: 2 Mg/Glove Max.
- Result: X-small 0.16 mg/glove, Small 0.20 mg/glove, Medium 0.21 mg/glove, Large 0.20 mg/glove, X-Large 0.21 mg/glove.

BIO-COMPATIBILITY DATA:

ISO 10993-10 Biological Evaluation of Medical Devices Test for Irritation and Skin Sensitization. Test done for irritation:
- Purpose: To determine the potential of the material under test to produce dermal irritation in Rabbits.
- Acceptance Criteria: Under the condition of study not an irritant.
- Result: Under the condition of study not an irritant.
ISO 10993-10 Biological Evaluation of Medical Devices Test for Irritation and Skin Sensitization. Test done Skin sensitization:
- Purpose: To determine the skin sensitization potential of the material both in terms of induction and elicitation in Guinea Pig.
- Acceptance Criteria: Under the conditions of the study not a sensitizer.
- Result: Under the conditions of the study not a sensitizer.
ISO 10993-5:2009 biological evaluation of medical devices - part 5, tests for in vitro cytotoxicity:
- Purpose: To evaluate the in vitro cytotoxic potential of the test item (both inner and outer surface) Extracts in L-929 mouse fibroblasts cells using elution method.
- Acceptance Criteria: Under the conditions of study non cytotoxic.
- Result: Under the conditions of the study, cytotoxic. Additional testing was performed to determine if this was a systemic toxicity concern.
ISO 10993-11:2017 biological evaluation of medical devices - part 11, tests for systemic toxicity:
- Purpose: To determine the acute systemic toxicity potential of the test item extracts (both inside and outer surfaces) in swiss Albino mice.
- Acceptance Criteria: Under the conditions of study the device extracts do not pose a systemic toxicity concern.
- Result: Under the conditions of study the device extracts do not pose a systemic toxicity concern.
USP 41 Pyrogen Test:
- Purpose: To determine the pyrogenic potential of the test item extract following intravenous injection in New Zealand white Rabbits.
- Acceptance Criteria: Under the conditions of the study, the device did not demonstrate a material mediated pyrogenicity response.
- Result: Under the conditions of the study, the device did not demonstrate a material mediated pyrogenicity response.

Clinical Testing Summary:
Not applicable - Clinical data is not needed for gloves or for most devices cleared by the 510(k) process.

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.

K172930

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

0

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 seal of the Department of Health & Human Services. To the right of the seal is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below it. The logo is simple and professional, and it is easily recognizable.

January 24, 2020

JR Engineering & Medical Technologies (M) SDN.BHD. % Manoj Zacharias Consultant Liberty Management Group Ltd. 75 Executive Dr. STE 114 Aurora, Illinois 60504

Re: K192333

Trade/Device Name: Blue Nitrile Examination Gloves Powder Free Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I Product Code: LZA Dated: December 11, 2019 Received: December 16, 2019

Dear Manoj Zacharias:

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 (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.

For 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

2

Indications for Use

510(k) Number (if known) K192333

Device Name

Blue Nitrile Examination Gloves Powder Free

Indications for Use (Describe)

Blue Nitrile Examination Gloves Powder Free is disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 201 Subpart D)
Over-The-Counter Use (21 CFR 201 Subpart C)

__ Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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3

SUBMISSION OF PREMARKET NOTIFICATION (510K) FOR BLUE NITRILE EXAMINATION GLOVES POWDER FREE

510K SUMMARY as required by: 21CFR § 807.92(c) K192333

A. APPLICANT INFORMATION

510(k) Owner's Name	JR Engineering & Medical Technologies (M) SDN.BHD.
Address	Lot 8 & 10, Jalan Zurah 3, Lot 1 & 3, Jalan Zurah, 3A/1,
Pusat Perindustrian 2, 44200 Rasa, Selangor Darul
Ehsan, Malaysia.
Phone	+603-60572081
Fax	+603-60572181
E-mail	ganeshjrmt@gmail.com
Contact Person	Mr.Ganesan Subramaniam
Designation	Managing Director
Contact Number	+6012 224 6677
Contact Email	ganeshjrmt@gmail.com
Date Submitted	5th Aug 2019

B. DEVICE IDENTIFICATION

Name of the device	Blue Nitrile Examination Gloves Powder Free
Product proprietary or trade name	JR MEDIC
Common or usual name	Exam Gloves
Classification name	Patient Examination Gloves
Device Classification	Class-1
Product Code	LZA
Regulation Number	21 CFR 880.6250
Review Panel	General Hospital

C. Predicate Device

| Predicate Device | MCare Blue Nitrile Examination Gloves
Powder-free |
|------------------|------------------------------------------------------|
| 510( k) Number | K172930 |
| Regulatory Class | 1 |
| Product code | LZA |

D. DESCRIPTION OF THE DEVICE:

JR MEDIC Blue Nitrile Examination Gloves Powder Free are Class I patient examination gloves bearing the product code Nitrile - LZA (21CFR880.6250).

4

SUBMISSION OF PREMARKET NOTIFICATION (510K) FOR BLUE NITRILE EXAMINATION GLOVES POWDER FREE

The gloves are made from acrylonitrile-butadiene copolymer dispersion. These gloves are blue in color and are powder free.

E.INTENDED USE OF THE DEVICE:

JR MEDIC Blue Nitrile Examination Gloves Powder Free is disposable devices intended for medical purpose that are worn on the examiner's hand to prevent contamination between patient and examiner.

F. SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE

CHARACTERSTICS	STANDARDS	DEVICE PERFORMANCE		Remarks
		PREDICATE	SUBJECT
510(k) Number		K172930	K192333	----
Name of device		MCare Blue Nitrile
Examination Gloves
Powder Free	JR MEDIC Blue
Nitrile Examination
Gloves Powder Free	----
Dimensions	ASTMD6319-10
(Reapproved 2015)	Length Min 230 m
Width Min 95+/-10
mm(for medium
size)	Length Min 230 mm
Width Min 95+/-10
mm
(for medium size)	Same
Physical Properties	ASTMD6319-10
(Reapproved 2015)	Before Aging
Tensile Strength
min 14 Mpa
Ultimate Elongation
Min 500%
After Aging
Tensile Strength
min 14 Mpa
Ultimate Elongation
Min 400%	Before Aging
Tensile Strength
min 14 Mpa
Ultimate Elongation
Min 500%
After Aging
Tensile Strength
min 14 Mpa
Ultimate Elongation
Min 400%	Same
Thickness	ASTMD6319-10
(Reapproved 2015)	Palm min 0.05 mm
Finger min 0.05 mm	Palm min 0.05 mm
Finger min 0.05 mm	Same
Powder Free	ASTMD6319-10	≤2 mg/glove	≤2 mg/glove	Similar
Biocompatibility	Primary Skin
Irritation-ISO 10993-
10:2010(E)	Under the condition
of study not an
irritant	Under the condition
of study not an
irritant	Same
	Dermal Sensitization-
ISO 10993-10:2010(
E)	Under the conditions
of the study not a
sensitizer	Under the conditions
of the study not a
sensitizer	Same
	In vitro cytotoxicity
ISO10993-5 :2009(E)	Data Not available	Under the conditions
of the study,
cytotoxic.
Additional testing
was performed to
determine if this was
a systemic toxicity
concern	----

5

SUBMISSION OF PREMARKET NOTIFICATION (510K) FOR BLUE NITRILE EXAMINATION GLOVES POWDER FREE

POWDER FREE
Acute Systemic
Toxicity Test ISO
10993-11:2017(E)	Data Not available	Under the condition
of study the device
extracts do not pose a
systemic toxicity
concern	-----
Material Mediated
Pyrogenicity ISO
10993-11:2017(E) /
USP 41	Data Not available	Under the conditions
of the study, the
device did not
demonstrate a
material mediated
pyrogenicity
response.	-----

CHARACTERSTICS	STANDARDS	DEVICE PERFORMANCE		Remarks
		PREDICATE	CURRENT
Water Tight (1000 ml)	ASTM D5151-06	Passes	Passes AQL-2.5	Similar
Intended use		MCare Blue Nitrile
Examination
Gloves
Powder
free is disposable
devices
intended
for
medical
purpose that are
won on
the
examiner's hand to
prevent
contamination
between
patient
and examiner.	JR MEDIC Blue Nitrile
Examination
Gloves
Powder Free is disposable
devices intended
for
medical purpose that are
won on the examiner's
hand to
prevent
contamination
between
patient and examiner.	Similar
Material	ASTMD6910-10
(Reapproved

      | Nitrile                                                                                                                                                                                                                                            | Nitrile                                                                                                                                                                                                                                | Same    |

Labeling | Single Use | Single Use | Same |
| Manufacturer(s) | - | Mercator Medical
(Thailand) LTD | JR Engineering &
Medical Technologies
(M) SDN.BHD.
Malaysia | ----- |

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 D6913-10.

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SUBMISSION OF PREMARKET NOTIFICATION (510K) FOR BLUE NITRILE EXAMINATION GLOVES POWDER FREE

G. Non-Clinical Testing Summary

PERFORMANCE DATA

Test Method	Purpose	Acceptance Criteria	Result
ASTM D6319-10 (Reapproved

Standard Specification
for Nitrile Examination Gloves
for Medical Application | To determine the
length of the gloves | Min 230 mm for all sizes | X-Small:-404 mm
Small:-404 mm
Medium:-405 mm
Large:-404 mm
X-Large:-404 mm |
| ASTM D6319-10 (Reapproved
Standard Specification
for Nitrile Examination Gloves
for Medical Application | To determine the
width of the gloves | X-small:- 70+/-10 mm
Small:-80+/-10 mm
Medium:-95+/-10 mm
Large:-110+/-10 mm
X-Large:-120+/-10 mm | X-small:-74 mm
Small:-84 mm
Medium:-94 mm
Large:-105 mm
X-Large:-115 mm |

Test Method	Purpose	Acceptance Criteria	Result
ASTM D6319-10 (Reapproved

Standard Specification
for Nitrile Examination Gloves
for Medical Application | To determine the
thickness of the
gloves | Palm 0.05 mm min
Finger 0.05 mm min
for all sizes | Size                Palm                Finger
X-Small                0.20mm                0.22mm
Small                    0.19mm                0.21mm
Medium                0.20mm                0.22mm
Large                    0.20mm                0.21mm
X-Large                0.20mm                0.22mm |
| | To Determine the
physical properties-
Tensile strength | Before Ageing
Tensile Strength
14Mpa Min for all
sizes
After Ageing
Tensile Strength
14Mpa Min for all
sizes | Size                Before                After
ageing                ageing
X-Small                22.0Mpa                18.5Mpa
Small                    23.0Mpa                20.5Mpa
Medium                25.6Mpa                22.0 Mpa
Large                    24.0Mpa                21.0Mpa
X-Large                24.5Mpa                21.7Mpa |
| ASTM D6319-10 (Reapproved
Standard Specification
for Nitrile Examination Gloves
for Medical Application | To Determine the
physical properties-
Ultimate Elongation | Before Ageing
Ultimate Elongation
500% Min for all
sizes
After Ageing
Ultimate
Elongation 400%
Min for all sizes | Size                Before                After
ageing                ageing
X-Small                898%                    872%
Small                    896%                    861%
Medium                868%                    828%
Large                    899%                    869%
X-Large                874%                    853% |

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SUBMISSION OF PREMARKET NOTIFICATION (510K) FOR BLUE NITRILE EXAMINATION GLOVES POWDER FREE

Test Method	Purpose	Acceptance Criteria	Result
ASTM D5151-06 (Reapproved

Standard Test Method
for Detection of Holes in
Medical Gloves | To determine the
holes in the gloves | AQL 2.5 | Gloves Passes AQL 1.5 |
| ASTM D6124-06 (Reapproved
Standard Test Method
for Residual Powder on
Medical Gloves | To determine the
residual powder in the
gloves | 2 Mg/Glove Max | Size
X-small 0.16 mg/glove
Small 0.20 mg/glove
Medium 0.21 mg/glove
Large 0.20 mg/glove
X-Large 0.21 mg/glove |

BIO-COMPATIBILITY DATA

Test Method	Purpose	Acceptance Criteria	Result
ISO
10993-10 Biological
Evaluation of Medical Devices
Test for Irritation and Skin
Sensitization. Test done for
irritation.	To determine the potential of
the material under test to
produce dermal irritation in
Rabbits	Under the condition
of study not an
irritant	Under the condition of
study not an irritant
ISO 10993-10 Biological
Evaluation of Medical Devices
Test for Irritation and Skin
Sensitization. Test done Skin
sensitization.	To determine the skin
sensitization potential of the
material both in terms of
induction and elicitation in
Guinea Pig.	Under the
conditions of the
study not a
sensitizer	Under the conditions of
the study not a
sensitizer
ISO 10993-5:2009 biological
evaluation of medical devices -
part 5, tests for in vitro
cytotoxicity.	To evaluate the in vitro
cytotoxic potential of the test
item (both inner and outer
surface) Extracts
in L-929
mouse fibroblasts cells using
elution method.	Under the
conditions of study
non cytotoxic	Under the conditions of
the study, cytotoxic.
Additional testing was
performed to determine
if this was a systemic
toxicity concern.
ISO 10993-11:2017 biological
evaluation of medical devices -
part 11, tests for systemic
toxicity.	To determine the acute
systemic toxicity potential of
the test item extracts (both
inside and outer surfaces) in
swiss Albino mice.	Under the
conditions of study
the device extracts
do not pose a
systemic toxicity
concern	Under the conditions
of study the device
extracts do not pose a
systemic toxicity
concern
USP 41 Pyrogen Test.	To determine the pyrogenic
potential of the test item
extract following intravenous
injection in New Zealand
white Rabbits.	Under the
conditions of the
study, the device
did not
demonstrate a
material mediated
pyrogenicity
response.	Under the conditions of
the study, the device did
not demonstrate a
material mediated
pyrogenicity response.

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SUBMISSION OF PREMARKET NOTIFICATION (510K) FOR BLUE NITRILE EXAMINATION GLOVES POWDER FREE

H. Clinical Testing Summary

Not applicable - Clinical data is not needed for gloves or for most devices cleared by the 510(k) process.

I. CONCLUSION

The conclusions drawn from the nonclinical test demonstrate that the subject device in 510(K) submission K192333, Blue Nitrile Examination Gloves Powder Free is as safe, as effective, and performs as well as or better than the legally marketed predicate device K172930.