Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

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

Therapeutic

No
The device, Blue Latex Examination Powder Free Gloves, is intended to prevent contamination between patient and examiner by being worn on the examiner's hand, which is a preventive measure and not a therapeutic function.

Diagnostic

No
Explanation: The device, Blue Latex Examination Powder Free Gloves, is intended to prevent contamination between patient and examiner and does not perform any diagnostic function.

SaMD (Software as a Medical Device)

No

The device is a physical product (gloves) and the description focuses on material properties and performance based on ASTM standards, 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 "disposable devices intended for medical purpose that are worn on the examiner's hand to prevent contamination between patient and examiner." This describes a barrier device used for protection, not a device used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or treatment.
Device Description: The description focuses on the physical properties and manufacturing standards of the gloves.
Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
Performance Studies: The performance studies described focus on the physical and chemical properties of the gloves (strength, elongation, water tightness, etc.), which are relevant to their function as a barrier, not their diagnostic capability.

IVD devices are specifically designed to perform tests on samples like blood, urine, tissue, etc., to provide information about a person's health status. These gloves do not perform such tests.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

Product codes

LYY

Device Description

Blue Latex Examination Powder Free Gloves are manufactured to meet all the current specifications listed under the ASTM Specification D 3578-05 (Reapproved 2015), Standard Specification for Rubber Examination Gloves. They are made from Natural Rubber Latex. 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

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)

The subject device underwent non-clinical performance testing against the following standards:

ASTM D3578-05 (Reapproved 2015) Standard Specification for Rubber Examination Gloves. This test determined the length, width, thickness, tensile strength, and ultimate elongation of the gloves.
ASTM D5151-06 (Reapproved 2015) Standard Test Method for Detection of Holes in Medical Gloves. This test determined the holes in the gloves, with an acceptance criterion of AQL 2.5 and a result of AQL 1.5.
ASTM D6124-06 (Reapproved 2017) Standard Test Method for Residual Powder on Medical Gloves. This test determined the residual powder in the gloves, with an acceptance criterion of 2 mg/glove Max.
ASTM D 5712-95 (Reapproved 2010) Standard Test Method for the Analysis of Protein in Natural Rubber. This test determined the extractable protein in the gloves, with an acceptance criterion of 200 µg/dm² Max.

Biocompatibility tests included:

Primary Skin Irritation-ISO 10993-10:2010(E): Resulted in "not an irritant."
Dermal Sensitization-ISO 10993-10:2010(E): Resulted in "not a sensitizer."
In vitro cytotoxicity ISO10993-5:2009(E): Resulted in "cytotoxic which is to be expected as latex is the positive control for this test."
Material mediated Pyrogenicity ISO 10993-11:2017(E)/USP: Resulted in "non-pyrogenic."

All non-clinical tests showed that the device meets the specified acceptance criteria.

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

Length: Min 230 mm for all sizes. Results: Small: 304 mm, Medium: 304 mm, Large: 305 mm, X-Large: 305 mm, XX-Large: 305 mm.
Width: Small: 80+/-6 mm, Medium: 95+/-6 mm, Large: 105+/-6 mm, X-Large: 114+/-6 mm, XX-Large: 120+/-6 mm. Results: Small: 84 mm, Medium: 94 mm, Large: 105 mm, X-Large: 114 mm, XX-Large: 123 mm.
Thickness: Palm 0.08 mm min, Finger 0.08 mm min for all sizes. Results (Palm/Finger): Small: 0.31mm/0.38mm, Medium: 0.31mm/0.38mm, Large: 0.31mm/0.38mm, X-Large: 0.31mm/0.38mm, XX-Large: 0.31mm/0.38mm.
Tensile Strength (Before Ageing): 18 Mpa Min. Results: Small: 33 Mpa, Medium: 32.9 Mpa, Large: 32.2 Mpa, X-Large: 31.9 Mpa, XX-Large: 31.1 Mpa.
Tensile Strength (After Ageing): 14 Mpa Min. Results: Small: 30 Mpa, Medium: 30.6 Mpa, Large: 29.9 Mpa, X-Large: 29.7 Mpa, XX-Large: 28.2 Mpa.
Ultimate Elongation (Before Ageing): 650% Min. Results: Small: 1322%, Medium: 1250%, Large: 1392%, X-Large: 1130%, XX-Large: 1149%.
Ultimate Elongation (After Ageing): 500% Min. Results: Small: 1046%, Medium: 1122%, Large: 1257%, X-Large: 1011%, XX-Large: 1110%.
Water Tight: AQL 2.5. Result: Passes AQL 1.5.
Residual Powder: 2 Mg/Glove Max. Results: Small: 0.20 mg/glove, Medium: 0.21 mg/glove, Large: 0.22 mg/glove, X-Large: 0.22 mg/glove, XX-Large: 0.23 mg/glove.
Extractable Protein: 200 µg/dm² Max. Results: Small: 45 µg/dm², Medium: 44 µg/dm², Large: 44 µg/dm², X-Large: 43 µg/dm², XX-Large: 45 µg/dm².

Predicate Device(s)

K141042

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 shows the logo of the U.S. Food and 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.

November 25, 2019

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

Re: K192329

Trade/Device Name: Blue Latex Examination Powder Free Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LYY Dated: August 24, 2019 Received: August 27, 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.

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

1

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 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 for THT4B2 Acting Assistant Director for THT4B1 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

2

Indications for Use

510(k) Number (if known) K192329

Device Name

Blue Latex Examination Powder Free Gloves

Indications for Use (Describe)

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

Type of Use (Select one or both, as applicable)
Residential Use - Part of STR 30A Subarea Plan Owner - Time Construction with STR 30A Subarea Plan

__ Prescription Use (Part 21 CFR 801 Subpart D)

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

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510K SUMMARY K192329 as required by 21 CFR § 807.92

A. APPLICANT INFORMATION

Applicant	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	November 24th 2019

B. DEVICE IDENTIFICATION

Name of the device	Blue Latex Examination Powder Free Gloves
Product proprietary or trade name	Blue Latex Examination Powder Free Gloves
Common or usual name	Latex Examination Gloves Powder Free
Classification name	Patient Examination Glove
Device Classification	Class I
Product Code	LYY
Regulation Number	21 CFR 880.6250
Review Panel	General Hospital

C. PREDICATE DEVICE

| Legally Marketed devices that

Equivalency is claimed	MCARE PF Powder-free Latex Examination Gloves
510 (K) Number	K141042
Regulatory Class	Class I
Product code	LYY

D. DESCRIPTION OF THE DEVICE:

Blue Latex Examination Powder Free Gloves are manufactured to meet all the current specifications listed under the ASTM Specification D 3578-05 (Reapproved 2015), Standard Specification for Rubber Examination Gloves. They are made from Natural Rubber Latex. These gloves are blue in color and are powder free.

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E. INDICATIONS FOR USE/INTENDED USE OF THE DEVICE:

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

F. TECHNOLOGICAL CHARACTERISTICS

CHARACTERSTICS	STANDARDS	DEVICE PERFORMANCE		Comparison
		PREDICATE	SUBJECT
510(k) Number	---	K141042	K192329	---
Name of device	---	MCARE PF
Powder Free
Latex
Examination
Gloves	Blue Latex Examination
Powder Free Gloves	---
Dimensions- Length	ASTMD3578-05
(Reapproved

                           | Length > 230 mm                                                                                | Length > 230 mm

650%
After Ageing
Ultimate Elongation
500% | Before Ageing
Ultimate Elongation > 650%
Size Actual value Small 1322 Medium 1250 Large 1392 X-Large 1130 XX-Large 1149
After Ageing
Ultimate Elongation > 500%
Size Actual value Small 1046 Medium 1122 Large 1257 X-Large 1011 XX-Large 1110 | | | | | | | | | | | | | | | | | | | | | | | | | Similar |
| Dimensions- Width | ASTMD3578-05
(Reapproved

                           | Width Min 95+/-

18 Mpa_
After Ageing
Tensile Strength
14 Mpa | Before Ageing
Tensile Strength > 18 Mpa
Size Actual value Small 33.0 Medium 32.9 Large 32.2 X-Large 31.9 XX-Large 31.1
After Ageing
Tensile Strength > 14 Mpa Size Actual value Small 30.0 Medium 30.6 Large 29.9 X-Large 29.7 XX-Large 28.2 | | | | | | | | | | | | | | | | | | | | | | | | | Similar |
| Thickness | ASTMD3578-05
(Reapproved 2015) | Palm > 0.08 mm
Finger > 0.08 mm | Palm > 0.08 mm
Finger > 0.08 mm
Size Palm
(Actual value) Finger
(Actual value) Small 0.31 0.38 Medium 0.31 0.38 Large 0.31 0.38 X-Large 0.31 0.38 XX-Large 0.31 0.38 | | | | | | | | | | | | | | | | | | | Similar | | | | | | |
| Powder Free Residue | ASTMDD6319-10
(Reapproved 2015) | $\leq$ 2 mg/glove | $\leq$ 2 mg/glove
Size Residual
powder content
(mg/glove) Small 0.20 Medium 0.21 Large 0.22 X-Large 0.22 XX-Large 0.23 | | | | | | | | | | | | | 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) | / | | Under the conditions of the
study, cytotoxic which is to be
expected as latex is the positive
control for this test. | Different | | | | | | | | | | | | | | | | | | | | | | | |
| | Material mediated
Pyrogenicity
ISO 10993-
11:2017(E) / USP | Data Not available | | Under the conditions of the
study, non-pyrogenic | --- | | | | | | | | | | | | | | | | | | | | | | | |

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CHARACTERSTICS	STANDARDS	DEVICE PERFORMANCE		Comparison
		PREDICATE	CURRENT
510(k) Number		K141042	K192329
Water Tight (1000 ml)	ASTM D5151-06
(Reapproved 2015)	Passes	Passes AQL-2.5	Same
Intended use		The mCare Powder Free Latex
Examination Blue
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.	Blue Latex Examination
Powder Free Gloves are
disposable devices intended
for medical purpose that are
worn on the examiner's hand
to prevent contamination
between patient and examiner.	Same
Material		Natural Latex	Natural Latex	Identical
Color		Blue	Blue	Identical
Texture		Finger Texture	Finger texture	Identical
Size	ASTMD 3578-5
(Reapproved 2015)	Small, Medium,
Large, X Large &
XX Large	Small, Medium, Large, X
Large & XX Large	Same
Single Use	Medical Glove
Guidance Manual

Labeling | Single Use | Single Use | Same |
| Sterile/non sterile | - | Non sterile | Non sterile | Same |
| Powder/Powder free | - | Powder free | Powder free | Same |
| Label and Labeling | FDA Label
requirements | Meets FDA's label
and labeling
requirements | Meets FDA's label and
labeling requirements | Same |
| Manufacturer(s) | | Mercator Medical
(Thailand) LTD | JR Engineering & Medical
Technologies (M) SDN.BHD.
Malaysia | --- |

G. SUMMARY OF NON-CLINICAL PERFORMANCE DATA

Test Method	Purpose	Acceptance Criteria	Result
ASTM D3578-05 (Reapproved

Standard Specification
for Rubber Examination
Gloves | To determine the
length of the gloves | Min 230 mm for all sizes | Small:-304 mm
Medium:-304mm
Large:-305mm
X-Large:-305mm
XX-Large:-305 mm | |
| ASTM D3578-05 (Reapproved
Standard Specification
for Rubber Examination
Gloves | To determine the
width of the gloves | Small:-80+/-6 mm
Medium:-95+/-6mm
Large:-105+/-6 mm
X-Large:-114+/-6 mm
XX-Large:-120 +/-6 mm | Small:-84 mm
Medium:-94 mm
Large:-105 mm
X-Large:-114 mm
XX-Large:-123 mm | |
| Test Method | Purpose | Acceptance Criteria | Result | |
| ASTM D3578-05 (Reapproved 2015) Standard Specification for Rubber Examination Gloves | To determine the thickness of the gloves | Palm 0.08 mm min
Finger 0.08 mm min for all sizes | Size
Small
Medium
Large
X-Large
XX-Large | Palm Finger
0.31mm 0.38mm
0.31mm 0.38mm
0.31mm 0.38mm
0.31mm 0.38mm
0.31mm 0.38mm |
| ASTM D3578-05 (Reapproved 2015) Standard Specification for Rubber Examination Gloves | To Determine the physical properties-Tensile strength | Before Ageing Tensile Strength 18Mpa Min for all sizes
After Ageing Tensile Strength 14Mpa Min for all sizes | Size
Small
Medium
Large
X-Large
XX-Large | Before ageing After ageing
33Mpa 30Mpa
32.9Mpa 30.6Mpa
32.2Mpa 29.9Mpa
31.9Mpa 29.7Mpa
31.1Mpa 28.2Mpa |
| ASTM D3578-05 (Reapproved 2015) Standard Specification for Rubber Examination Gloves | To Determine the physical properties-Ultimate Elongation | Before Ageing Ultimate Elongation 650% Min for all sizes
After Ageing Ultimate Elongation 500% Min for all sizes | Size
Small
Medium
Large
X-Large
XX-Large | Before ageing After ageing
1322% 1046%
1250% 1122%
1392% 1257%
1130% 1011%
1149% 1110% |
| | To Determine the physical properties-stress at 500% Elongation | Before Ageing 5.5 Mpa Max for all sizes | Size
Small
Medium
Large
X-Large
XX-Large | Before ageing NA
5.1 Mpa
5.2 Mpa
5.2 Mpa
5.1 Mpa
5.2 Mpa |
| ASTM D5151-06 (Reapproved 2015) 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 2017) Standard Test Method for Residual Powder on Medical Gloves | To determine the residual powder in the gloves | 2 Mg/Glove Max | Size
Small
Medium
Large
X-Large
XX-Large | Residual Powder Content
0.20 mg/glove
0.21 mg/glove
0.22 mg/glove
0.22 mg/glove
0.23 mg/glove |
| ASTM D 5712-95 ( Re approved 2010) Standard Test Method for the Analysis of Protein in Natural Rubber | To determine the extractable protein in the gloves. | 200 µg/ dm² Max for all sizes | Size
Small
Medium
Large
X-Large
XX-Large | Extractable Protein content
45 µg/ dm²
44 µg/ dm²
44 µg/ dm²
43 µg/ dm²
45 µg/ dm² |

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The performance test data of the non-clinical tests meet following standards: ASTMD 3578-5 (Reapproved 2015) Standard Specification for Rubber Examination Gloves ASTM D5151-06 (Reapproved 2015) Standard Test Method for Detection of Holes in Medical Gloves ASTM D6124-06 (Reapproved 2017) Standard Test Method for Residual Powder on Medical Gloves ASTM D 5712-95 ( Re approved 2010) Standard Test Method for the Analysis of Protein in Natural Rubber

H.CONCLUSION

The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission K 192329, Blue Latex Examination Powder Free Gloves is as effective, and performs as well as or better than the legally marketed predicate device K141042.