JR MEDIC

K222348 · Jr Engineering & Medical Technologies (M) Sdn. Bhd. · LYY · Oct 27, 2022 · General Hospital

Device Facts

• Record ID: K222348
• Device Name: JR MEDIC
• Applicant: Jr Engineering & Medical Technologies (M) Sdn. Bhd.
• Product Code: LYY · General Hospital
• Decision Date: Oct 27, 2022
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

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.

Device Story

Latex Examination Powder Free Gloves are non-sterile, natural rubber latex gloves used in medical settings to prevent cross-contamination between patients and examiners. The device is worn on the hands of healthcare personnel. It functions as a physical barrier. The device is manufactured to meet ASTM D3578-2019 specifications for dimensions, physical properties (tensile strength, elongation), and barrier integrity. It is provided as a powder-free, single-use product. The device benefits patients and clinicians by reducing the risk of infection transmission during examinations.

Clinical Evidence

No clinical data. Bench testing only, including ASTM D3578 (dimensions, physical properties), ASTM D5151 (water-tight/holes), ASTM D6124 (residual powder), and ASTM D5712 (protein content). Biocompatibility testing performed per ISO 10993-5, 10993-10, and 10993-11.

Technological Characteristics

Material: Natural Rubber Latex. Form factor: Disposable, non-sterile, powder-free examination glove. Dimensions: Length > 230 mm. Standards: ASTM D3578-2019 (physical properties), ASTM D5151-2019 (barrier integrity), ASTM D6124-06 (residual powder), ASTM D5712-95 (protein content). Biocompatibility: ISO 10993-5 (cytotoxicity), ISO 10993-10 (irritation/sensitization), ISO 10993-11 (acute systemic toxicity).

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hand to prevent cross-contamination between patient and examiner.

Regulatory Classification

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.

Predicate Devices

• JR Medic Powder free Latex Examination Gloves (K192329)

Submission Summary (Full Text)

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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 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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 27, 2022

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

Re: K222348

Trade/Device Name: 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: September 28, 2022 Received: September 28, 2022

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.

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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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Bifeng Oian, M.D., 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) K222348

Device Name

Latex Examination Powder Free Gloves

#### Indications for Use (Describe)

Latex Examination Powder Free Gloves are 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 801 Subpart D)

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

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# 510K SUMMARY

# K22348

## As required by 21CFR§807.92(c)

### 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<br>Perindustrian 2, 44200 Rasa, Hulu Selangor, Selangor Darul Ehsan,<br>Malaysia. |
| Phone | [phone] |
| Fax | [phone] |
| E-mail | [e-mail] |
| Contact Person | Mr. Ganesan Subramaniam |
| Designation | Managing Director |
| Contact Number | [phone] |
| Contact Email | [e-mail] |
| Date Submitted | 27 October 2022 |

#### B. DEVICE IDENTIFICATION

| Name of the device | Latex Examination Powder Free Gloves |
|--------------------------------------|--------------------------------------|
| Product proprietary or<br>trade name | JR MEDIC |
| Common or usual name | Latex Examination Powder Free Gloves |
| Classification name | Patient Examination Gloves |
| Device Classification | Class I |
| Product Code | LYY |
| Regulation Number | 21 CFR 880.6250 |
| Review Panel | General Hospital |

### C. PREDICATE DEVICE

| Legally Marketed devices | JR Medic Powder free Latex Examination Gloves |
|-----------------------------|-----------------------------------------------|
| that Equivalency is claimed | |
| 510(K) Number | K192329 |
| Regulatory Class | Class I |
| Product code | LYY |

## D. DESCRIPTION OF THE DEVICE:

Latex Examination Powder Free Gloves are manufactured to meet all the current specifications listed under the ASTM Specification D3578-2019, Standard Specification for Rubber Examination Gloves. They are made from Natural Rubber Latex. These gloves are natural in color (No color is added) and are powder free and Non-Sterile.

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

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.

#### Device Performance Characteristics Standards Comparison Predicate Current K192329 K222348 510(K) Number ---Name of device JR MEDIC Blue Latex Examination ---Latex Powder Free Gloves Examination Powder Free Gloves Dimensions-Length > 230 mm Length > 230 mm ASTM Length D3578-2019 Size Average X-Small 305 Small 306 Medium 307 Large 308 X-Large 310 Dimensions- Width Width Min 95+/-ASTM Width Min 95+/-10 D3578-2019 10 mm (for mm (for medium medium size) size) Siz Average e X-Small 76 Small 82 Medium 96 Large 1 06 X-Large 116 Physical Before Ageing ASTM Before Ageing Properties-D3578-2019 Tensile Strength Tensile Strength > 18 Mpa Tensile > 18 Mpa Siz Actual Strength value e X-Small 22.07 Small 22.15 22.22 Medium Large 22.30 22.32 X-Large After Ageing After Ageing Tensile Tensile Strength > 14 Mpa Strength

> 14 Mpa

## F. TECHNOLOGICAL CHARACTERISTICS

---

Similar

Similar

Similar

Similar

Siz

e

X-Small

Medium

X-Large

Small

Large

Actual

value

18.49

18:56

18.67

18.74

18.76

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| Characteristics | Standards | Device Performance | | Comparison | | | | | | | | | | | | | | | | | | |
|---------------------------------------------------|---------------------------------------------------------------------------|-----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|
| | | Predicate | Current | | | | | | | | | | | | | | | | | | | |
| 510(K) Number | | K192329 | K222348 | | | | | | | | | | | | | | | | | | | |
| Physical<br>Properties-<br>Ultimate<br>Elongation | ASTM<br>D3578-2019 | Before Ageing<br>Ultimate<br>Elongation<br>> 650% | Before Ageing<br>Ultimate Elongation > 650% | Similar | | | | | | | | | | | | | | | | | | |
| | | | Size Actual value X-Small 858 Small 869 Medium 874 Large 880 X-Large 882 | | | | | | | | | | | | | | | | | | | |
| | | After Ageing<br>Ultimate<br>Elongation<br>>500% | After Ageing<br>Ultimate Elongation > 500% | | | | | | | | | | | | | | | | | | | |
| | | | Size Actual value X-Small 841 Small 848 Medium 854 Large 860 X-Large 862 | | | | | | | | | | | | | | | | | | | |
| Thickness | ASTM<br>D3578-2019 | Palm > 0.08 mm<br>Finger > 0.08 mm | Palm > 0.08 mm<br>Finger > 0.08 mm | Similar | | | | | | | | | | | | | | | | | | |
| | | | Size Palm<br>(Actual<br>value) Finger<br>(Actual<br>value) X-Small 0.16 0.22 Small 0.16 0.22 Medium 0.16 0.22 Large 0.16 0.22 X-Large 0.16 0.22 | | | | | | | | | | | | | | | | | | | |
| Powder Free<br>Residue | ASTM D6214 | ≤2 mg/glove | ≤2 mg/glove | Similar | | | | | | | | | | | | | | | | | | |
| | | | Size Residual<br>powder content<br>(mg/glove) X-Small 0.21 Small 0.21 Medium 0.22 Large 0.22 X-Large 0.22 | | | | | | | | | | | | | | | | | | | |
| Protein Content | ASTM D5712 | Max 200 µg/ dm2 | 43.19 µg/ dm2 | Similar | | | | | | | | | | | | | | | | | | |
| Biocompatibility | Primary Skin<br>Irritation-ISO<br>10993-10:2010(E) | Under the condition<br>of study, not an<br>irritant | Under the condition of study<br>not an irritant | Same | | | | | | | | | | | | | | | | | | |
| | Dermal Sensitization-<br>ISO 10993-10:2010(<br>E) | Under the conditions<br>of the study, not a<br>sensitizer | Under the conditions of the<br>study, not a sensitizer | Same | | | | | | | | | | | | | | | | | | |
| | In vitro cytotoxicity<br>ISO10993-5<br>:2009(E) | Under the conditions<br>of the study,<br>cytotoxic | Under the conditions of the<br>study, cytotoxic | Same | | | | | | | | | | | | | | | | | | |
| | Material mediated<br>Pyrogenicity<br>ISO 1099311:2017(E)<br>/ USP 41<151> | Under the<br>conditions of the<br>study non | No data available | ---- | | | | | | | | | | | | | | | | | | |

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| Characteristics | Standards | Device Performance | | Comparison |
|-------------------------------------|---------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| | | Predicate | Current | |
| 510(K) Number | | K192329 | K222348 | |
| Biocompatibility | Acute Systemic<br>Toxicity Test ISO<br>10993-11:2017(E) | Under the conditions<br>of study the device<br>extracts do not pose a<br>systemic toxicity<br>concern | Under the conditions<br>of study the device extracts<br>do not pose a systemic<br>toxicity concern | same |
| Water Tight<br>(1000 ml) | ASTM D5151-2019 | Passes AQL-1.5 | Passes AQL-1.5 | Same |
| Intended use/<br>Indication for use | | JR MEDIC Blue Latex<br>Examination Powder<br>Free Gloves are<br>disposable devices<br>intended for medical<br>purpose that are won<br>on the examiner's<br>hand to prevent<br>contamination<br>between patient and<br>examiner. | Latex Examination Powder<br>Free Gloves are disposable<br>devices intended for medical<br>purpose that are worn on the<br>examiner's hand to prevent<br>contamination between<br>patient and examiner. | Similar |
| Material | - | Natural Latex | Natural Latex | Same |
| Color | - | Blue | Natural (No color is added) | different |
| Texture | - | Finger Texture | Finger texture | Same |
| Size | ASTM D3578-<br>2019 | Small, Medium, Large<br>& X Large | X Small, Small,<br>Medium, Large, X-Large | Similar |
| Single Use | Medical Glove<br>Guidance Manual<br>- Labeling | Single Use | Single Use | Same |
| Sterile/non sterile | - | Non sterile | Non sterile | Same |
| Powder/Powder<br>free | - | Powder free | Powder free | Same |
| Label and Labeling | FDA Label<br>requirements | Meets FDA's label<br>and labeling<br>requirements | Meets FDA's label<br>and labeling<br>requirements | Same |
| Manufacturer(s) | - | JR Engineering &<br>Medical Technologies<br>(M) SDN.BHD.<br>Malaysia | JR Engineering & Medical<br>Technologies (M) SDN.BHD.<br>Malaysia | Same |

# G. SUMMARY OF NON-CLINICAL PERFORMANCE DATA

| Test Method | Purpose | Acceptance Criteria | Result | |
|----------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ASTM D3578-2019 Standard<br>Specification for Rubber Examination<br>Gloves | To determine the<br>length of the gloves | Min 230 mm for all sizes | X-Small 305 mm<br>Small 306 mm<br>Medium 307 mm<br>Large 308 mm<br>X-Large 310 mm | |
| ASTM D3578-2019 Standard<br>Specification for Rubber Examination<br>Gloves | To determine the width<br>of the gloves | X-Small 70+/-10 mm<br>Small 80+/-10mm<br>Medium 95+/-10 mm<br>Large 111+/-10 mm<br>X-Large 115+/-10 mm | X-Small 76 mm<br>Small 85 mm<br>Medium 96 mm<br>Large 106 mm<br>X-Large 116 mm | |
| Test Method | Purpose | Acceptance Criteria | Result | |
| ASTM D3578-2019 Standard<br>Specification for Rubber<br>Examination Gloves | To determine the thickness of<br>the gloves | Palm 0.08 mm min<br>Finger 0.08 mm min<br>for all sizes | Size<br>X-Small<br>Small<br>Medium<br>Large<br>X-Large | Palm     Finger<br>0.16mm    0.22mm<br>0.16mm    0.22mm<br>0.16mm    0.22mm<br>0.16mm    0.22mm<br>0.16mm    0.22mm |
| ASTM D3578-2019<br>Standard Specification for<br>Rubber Examination Gloves | To Determine the physical<br>properties-Tensile strength | Before Ageing<br>Tensile Strength<br>18Mpa Min for all<br>sizes<br>After Ageing<br>Tensile Strength<br>14Mpa Min for all<br>sizes | Size<br>X-Small<br>Small<br>Medium<br>Large<br>X-Large | Before ageing    After ageing<br>22.07 Mpa      18.49 Mpa<br>22.15 Mpa      18.56 Mpa<br>22.22 Mpa      18.67 Mpa<br>22.30 Mpa      18.74 Mpa<br>22.32 Mpa      18.76 Mpa |
| ASTM D3578-2019<br>Standard Specification for<br>Rubber Examination Gloves | To Determine the physical<br>properties-Ultimate Elongation | Before Ageing<br>Ultimate Elongation<br>650% Min for all<br>sizes<br>After Ageing<br>Ultimate Elongation<br>500% Min for all<br>sizes | Size<br>X-Small<br>Small<br>Medium<br>Large<br>X-Large | Before ageing    After ageing<br>858%             841%<br>869%             848%<br>874%             854%<br>880%             860%<br>882%             862% |
| | To Determine the physical<br>properties-stress at 500%<br>Elongation | Before Ageing<br>5.5 Mpa Max for all<br>sizes | Size<br>X-Small<br>Small<br>Medium<br>Large<br>X-Large | Before<br>ageing             NA<br>5.1 Mpa<br>5.1 Mpa<br>5.2 Mpa<br>5.2 Mpa<br>5.2 Mpa |
| ASTM D5151-2019 Standard<br>Test Method for Detection of<br>Holes in Medical Gloves | To determine the holes in the<br>gloves | AQL 2.5 | Gloves Passes AQL 1.5 | |
| ASTM D6124-06<br>(Reapproved 2017) Standard<br>Test Method for Residual<br>Powder on Medical Gloves | To determine the residual<br>powder in the gloves | 2 Mg/Glove Max | Size<br>X-Small<br>Small<br>Medium<br>Large<br>X-Large | Residual Powder<br>Content<br>0.21 mg/glove<br>0.21 mg/glove<br>0.22 mg/glove<br>0.22 mg/glove<br>0.22 mg/glove |
| ASTM D 5712-95 ( Re<br>approved 2010) Standard Test<br>Method for the Analysis of<br>Protein in Natural Rubber | To determine the extractable<br>protein in the gloves. | 200 µg/dm² Max for<br>all sizes | Size<br>X-Small<br>Small<br>Medium<br>Large<br>X-Large | Extractable<br>Protein content<br>43.65 µg/dm²<br>43.65 µg/dm²<br>43.65 µg/dm²<br>43.65 µg/dm²<br>43.65 µg/dm² |

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## The performance test data of the non-clinical tests meet following standards:

- A ASTMD 3578-2019 Standard Specification for Rubber Examination Gloves
- ASTMD 5151-2019 Standard Test Method for Detection of Holes in Medical Gloves >
- > ASTMD 6124-06 (Reapproved 2017) Standard Test Method for Residual Powder on Medical Gloves
- > ASTMD 5712-95 (Re approved 2010) Standard Test Method for the Analysis of Protein in Natural Rubber

## H. SUMMARY OF CLINICAL TESTING

Not applicable

## I. CONCLUSION

The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission Latex Examination Powder Free Gloves is as effective, and performs as well as or better than the legally marketed predicate device K192329.