SHARK GLOVES Blue Nitrile Examination Gloves Powder Free, INCONGLOVE Blue Nitrile Examination Gloves Powder Free

K212308 · Srirungruang Global Co., Ltd. · LZA · Oct 29, 2021 · General Hospital

Device Facts

• Record ID: K212308
• Device Name: SHARK GLOVES Blue Nitrile Examination Gloves Powder Free, INCONGLOVE Blue Nitrile Examination Gloves Powder Free
• Applicant: Srirungruang Global Co., Ltd.
• Product Code: LZA · General Hospital
• Decision Date: Oct 29, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

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

Device Story

Disposable nitrile examination gloves; worn by healthcare professionals during patient examinations; prevents cross-contamination between patient and examiner. Manufactured from acrylonitrile-butadiene copolymer; blue color; powder-free; finger-textured. Device provides physical barrier protection. Used in clinical settings. Benefits include reduction of infection transmission risk during routine medical procedures.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included ASTM D6319-19 (dimensions, physical properties, thickness), ASTM D5151-19 (freedom from holes), and ASTM D6124-06 (residual powder). Biocompatibility testing performed per ISO 10993-10 (irritation/sensitization), ISO 10993-5 (cytotoxicity), and ISO 10993-11 (systemic toxicity/pyrogenicity).

Technological Characteristics

Material: Acrylonitrile-butadiene copolymer (nitrile). Standards: ASTM D6319-19, ASTM D5151-19, ASTM D6124-06. Biocompatibility: ISO 10993-5, 10, 11. Form factor: Disposable, powder-free, blue, finger-textured. Dimensions: Min 230mm length, min 0.05mm thickness. Non-sterile.

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 Blue Nitrile Examination Gloves Powder Free (K192333)

Submission Summary (Full Text)

{0}------------------------------------------------

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.

October 29, 2021

Srirungruang Global Co., LTD. % Aristotle Nafpliotis Regulatory Affairs Consultant/Engineer mdi Consultants. Inc. 55 Northern Blvd., Suite 200 Great Neck, New York 11021

Re: K212308

Trade/Device Name: SHARK GLOVES Blue Nitrile Examination Gloves Powder Free, INCONGLOVE Blue 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 Dated: September 27, 2021 Received: September 28, 2021

Dear Aristotle Nafpliotis:

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}------------------------------------------------

542 of the Act); 21 CFR 1000-1050.

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-

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

Sincerely.

Clarence W. Murray, III, PhD 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)

### K212308

### Device Name

SHARK GLOVES Blue Nitrile Examination Gloves Powder Free INCONGLOVE Blue Nitrile Examination Gloves Powder Free

Indications for Use (Describe)

SHARK GLOVES and INCONGLOVE Blue Nitrile Examination Gloves Powder Free 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) | |
|------------------------------------------------------------|-----------------------------------------------------------|
| <span></span> Prescription Use (Part 21 CFR 801 Subpart D) | <span></span> Over-The-Counter Use (21 CFR 801 Subpart C) |

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image is a logo for "Shark Gloves". The logo features a stylized shark fin above the word "SHARK" in a smaller font, stacked above the word "GLOVES" in a larger font. The text and shark fin are outlined in black, with the interior of the fin filled in with a dark blue color.

# 510(k) SUMMARY

The assigned 510(k) number is: K212308.

#### 1. Submitter's Identification:

- SRIRUNGRUANG GLOBAL CO., LTD Name:
51/7 MOO 1, MABPHAI, BANBUNG, CHONBURI 20170 THAILAND Address:

Phone no.: [phone]

[phone] Fax no:

| Contact person: | Mr.Suttichai Sripradub |
|-----------------|------------------------|
|-----------------|------------------------|

Designation: Managing Director

# Manufacturer:

| Name: | SRIRUNGRUANG GLOBAL CO., LTD |
|------------|-------------------------------------------------------|
| Address: | 51/7 MOO 1, MABPHAI, BANBUNG, CHONBURI 20170 THAILAND |
| Phone no.: | [phone] |
| Fax no: | [phone] |

Exporter: SRIRUNGRUANG GLOBAL CO., LTD.

Date Summary Prepared: May 31, 2021

{4}------------------------------------------------

Image /page/4/Picture/1 description: The image shows a logo for "Shark Gloves". The logo features a stylized shark fin in blue, with a white outline. Below the shark fin, the words "SHARK" and "GLOVES" are stacked on top of each other in a bold, sans-serif font, also in blue with a white outline. The overall design is clean and sporty.

#### 2. Device Identification

| Name of the Device: | SHARK GLOVES Blue Nitrile Examination Glove<br>Powder Free<br>INCONGLOVE Blue Nitrile Examination Gloves<br>Powder free |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------|
| Trade Name (s): | SHARK GLOVES, INCONGLOVE |
| Common or usual name: | Exam Gloves |
| Regulation Number: | 21 CFR 880.6250 |
| Regulation Name: | Non-powdered patient examination gloves. |
| Regulatory Class: | I |
| Product Code: | LZA |
| Review Panel: | General Hospital |

#### Information for the 510(k) Cleared Device (Predicate Device): 3.

| Predicate Device: | JR MEDIC Blue Nitrile Examination Gloves Powder<br>Free |
|-------------------|---------------------------------------------------------|
| Owner: | JR Engineering & Medical Technologies (M) SDN.BHD. |
| 510(k) Number: | K192333 |
| Regulatory Class: | I |
| Product Code: | LZA |

#### 4. Device Description:

SHARK GLOVES and INCONGLOVE 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

#### ട്. Indications for Use:

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

{5}------------------------------------------------

Image /page/5/Picture/1 description: The image shows a logo for "Shark Gloves". The logo features a stylized shark fin in blue, with a white outline, positioned above the text "SHARK" and "GLOVES", which are stacked on top of each other. The text is in a bold, sans-serif font, with a white outline and a black shadow, giving it a three-dimensional effect. The overall design is sporty and eye-catching.

#### 6. Technological Characteristic Comparison of Proposed and Predicate Devices:

| CHARACTERSTICS | STANDARDS | DEVICE PERFORMANCE | | Comparison |
|----------------------------------------------|----------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| | | PREDICATE | SUBJECT | |
| 510(k) Number | | K192333 | K212308 | ------ |
| Name of device | | Blue Nitrile<br>Examination Gloves<br>Powder Free | SHARK GLOVES and<br>INCONGLOVE | ------ |
| Dimensions | ASTMD6319-10<br>(Reapproved 2015)<br>ASTMD6319-19 | Length Min 230 mm<br>Width Min 95+/-10<br>mm(for medium size) | Length Min 230 mm<br>Width Min 95+/-10<br>mm(for medium size) | Same |
| Physical Properties | ASTMD6319-10<br>(Reapproved 2015)<br>ASTMD6319-19 | Before Aging<br>Tensile Strength<br>min 14 Mpa<br>Ultimate Elongation<br>Min 500%<br>After Aging<br>Tensile Strength<br>min 14 Mpa<br>Ultimate Elongation<br>Min 400% | Before Aging<br>Tensile Strength<br>min 14 Mpa<br>Ultimate Elongation Min<br>500%<br>After Aging<br>Tensile Strength<br>min 14 Mpa<br>Ultimate Elongation Min<br>400% | Similar |
| Thickness | ASTMD6319-10<br>(Reapproved 2015)<br>ASTMD6319-19 | Palm min 0.05 mm<br>Finger min 0.05 mm | Palm min 0.05 mm<br>Finger min 0.05 mm | Same |
| Powder Free, Powder<br>residue | ASTMD6319-10<br>ASTMD6319-19 | ≤2 mg/glove | ≤2 mg/glove | Similar |
| Biocompatibility | Primary Skin<br>Irritation-ISO 1993-<br>10:2010(E) | Under the condition of<br>study not an irritant | Under the condition of<br>study not an irritant | Same |
| | Dermal Sensitization-<br>ISO 10993-<br>10:2010(E) | Under the conditions<br>of the study not a<br>sensitizer | Under the conditions of<br>the study not a<br>sensitizer | Same |
| | In vitro cytotoxicity<br>ISO10993-5 :2009(E) | Under the conditions<br>of the study,<br>cytotoxic.<br>Additional testing was<br>performed to<br>determine if this was<br>a systemic toxicity<br>concern | Under the conditions of<br>the study, cytotoxic.<br>Additional testing was<br>performed to determine<br>if this was a systemic<br>toxicity<br>concern | Similar |
| | Acute Systemic<br>Toxicity Test ISO<br>10993-11:2017(E) | Under the condition<br>of study the device<br>extracts do not pose a<br>systemic toxicity<br>concern | Under the condition<br>of study the device<br>extracts do not pose a<br>systemic toxicity<br>concern | Similar |
| | Material Mediated<br>Pyrogenicity ISO<br>10993-11:2017(E) /<br>USP 41<151> | Under the conditions<br>of the study, the<br>device did not<br>demonstrate a<br>material mediated<br>pyrogenicity response. | Under the conditions of<br>the study, the device<br>did not demonstrate a<br>material mediated<br>pyrogenicity response. | Similar |
| Water Tight (1000 ml),<br>Freedom from holes | ASTM D5151-06<br>ASTM D5151-19 | Passes AQL-2.5 | Passes | Similar |
| Indications for Use | | JR MEDIC Blue<br>Nitrile Examination<br>Gloves Powder Free<br>is disposable device<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. | SHARK GLOVES and<br>INCONGLOVE Blue<br>Nitrile Examination<br>Gloves Powder Free are<br>disposable devices<br>intended for medical<br>purpose that are won on<br>the examiner's hand to<br>prevent contamination<br>between patient and<br>examiner. | Similar |
| Material | ASTMD6319-<br>10(Reapproved<br>ASTMD6319-19 | Nitrile | Nitrile | Same |
| Color | - | Blue | Blue | Same |
| Texture | - | Finger Texture | Finger texture | Same |
| Size | ASTMD6319-10<br>(Reapproved 2015)<br>ASTMD6319-19 | Extra Small, Small,<br>Medium, Large, Extra<br>Large | Small, Medium, Large,<br>Extra Large | Similar |
| Single Use | Medical Glove<br>Guidance Manual -<br>Labeling | Single Use | Single Use | Same |
| Manufacturer(s) | - | JR Engineering &<br>Medical Technologies<br>(M) SDN.BHD.<br>Malaysia. | SRIRUNGRUANG<br>GLOBAL CO., LTD.<br>51/7 ΜΟΟ 1,<br>MABPHAI, BANBUNG<br>,CHONBURI<br>20170 THAILAND | |

{6}------------------------------------------------

Image /page/6/Picture/1 description: The image shows a logo for "Shark Gloves". The logo features a stylized blue shark with a white outline. Below the shark, the words "SHARK" and "GLOVES" are stacked on top of each other in a bold, sans-serif font, also in blue with a white outline. The overall design is sporty and suggests a brand associated with athletic or protective gloves.

{7}------------------------------------------------

Image /page/7/Picture/1 description: The image is a logo for "Shark Gloves". The logo features a blue shark with a white outline above the word "GLOVES" in large, bold, red letters. The word "SHARK" is in smaller, black letters above the word "GLOVES".

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 standards.

#### 7. Summarv of Non-Clinical Testing:

{8}------------------------------------------------

Image /page/8/Picture/1 description: The image shows a logo for "Shark Gloves". The logo features a stylized blue shark with a white outline. Below the shark, the words "SHARK" and "GLOVES" are stacked on top of each other in a stylized font. The word "SHARK" is slightly smaller and positioned above the word "GLOVES".

| Test Method | Purpose | Acceptance Criteria | Result |
|------------------------------------------------------------------------------------------------------|------------------------------------------|------------------------------------------------------------------------------------------|-------------------------------------------------------------|
| ASTM D6319-19<br>Standard Specification for<br>Nitrile Examination Gloves<br>for Medical Application | To determine the<br>length of the gloves | Min 230 mm for all sizes | Small: Pass<br>Medium: Pass<br>Large: Pass<br>X-Large: Pass |
| ASTM D6319-19<br>Standard Specification for<br>Nitrile Examination Gloves<br>for Medical Application | To determine the<br>width of the gloves | Small: -80+/-10 mm<br>Medium: -95+/-10mm<br>Large: -110+/-10 mm<br>X-Large: -120+/-10 mm | Small: Pass<br>Medium: Pass<br>Large: Pass<br>X-Large: Pass |

| Test Method | Purpose | Acceptance Criteria | Result | | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|------------------------------|-----------------------------|
| ASTM D6319-19<br>Standard Specification for<br>Nitrile Examination Gloves<br>for Medical Application | To determine<br>the length of the<br>gloves | Palm 0.05 mm min<br>Finger 0.05 mm min<br>for all sizes | Size<br>Small<br>Medium<br>Large<br>X-large | Palm<br>Pass<br><br><br> | Finger<br>Pass<br><br><br> |
| ASTM D6319-19<br>Standard Specification<br>physical properties- for<br>Nitrile Examination Gloves<br>Ultimate Elongation for<br>Medical Application | To Determine<br>the physical<br>properties Tensile<br>strength | Before Ageing<br>Tensile Strength<br>14Mpa Min for all<br>sizes<br><br>After Ageing<br>Tensile Strength<br>14Mpa Min for all size | Size<br>Small<br>Medium<br>Large<br>X-large | <br><br>Pass<br><br> | <br><br>Pass<br><br> |
| | To Determine the<br>physical properties<br>Ultimate Elongation | Before Ageing<br>Ultimate Elongation<br>500% Min for all<br><br>Size After Ageing | Size<br>Small<br>Medium | Before<br>ageing<br><br>Pass | After<br>ageing<br><br>Pass |

{9}------------------------------------------------

Image /page/9/Picture/1 description: The image shows a logo for "Shark Gloves". The logo features a stylized blue shark with a white outline. Below the shark, the words "SHARK GLOVES" are written in a bold, stylized font, with "SHARK" stacked above "GLOVES". The text also has a white outline, making it stand out against the background.

| | | Ultimate Elongation<br>400% Min for all sizes | Large<br>X-large | | |
|--|--|-----------------------------------------------|------------------|--|--|
|--|--|-----------------------------------------------|------------------|--|--|

| Test Method | Purpose | Acceptance<br>Criteria | Result |
|--------------------------------------------------------------------------------------|------------------------------------------------------|------------------------|---------------------------------------------|
| ASTM D5151-19<br>Standard Test Method for<br>detection of holes in<br>medical gloves | To determine the holes<br>in the gloves | AQL 2.5 | Pass |
| ASTM D6124-06<br>Standard Test Method for<br>Residual Powder on<br>Medical Gloves | To determine the<br>residual powder in the<br>gloves | 2 Mg/Glove Max | Size<br>Small<br>Medium<br>Large<br>X-Large |
| | | | Residual Powder<br>Content<br>Pass |

The indications for use, materials, size and models are all similar. Both the subject and predicate devices are shown to be biocompatible and meet the specifications of the ASTM standard D6319-10.

# BIO-COMPATIBILITY DATA

| Test Method | Purpose | Acceptance Criteria | Result |
|-------------|---------|---------------------|--------|
|-------------|---------|---------------------|--------|

{10}------------------------------------------------

Image /page/10/Picture/1 description: The image is a logo for "Shark Gloves". The logo features a blue shark with a white outline. The words "SHARK" and "GLOVES" are stacked on top of each other in red font below the shark. The logo has a sporty and dynamic feel.

| ISO 10993-10:2010<br>Biological Evaluation of<br>Medical Devices Test for<br>Irritation and Skin<br>Sensitization. Test done for<br>irritation. | To determine the potential of<br>the material under test to<br>produce dermal irritation in<br>Rabbits | Under the condition of<br>study not an irritant | Under the condition<br>of study not an irritant |
|----------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| ISO10993-10:2010<br>Biological Evaluation of<br>Medical Devices Test for<br>Irritation and Skin<br>Sensitization. Test done Skin<br>sensitization. | To determine the skin<br>sensitization potential of the<br>material both in terms of<br>induction and elicitation in<br>Guinea Pig. | Under the conditions<br>of the study not a<br>sensitizer | Under the conditions<br>of the study not a<br>sensitizer |
| ISO 10993-5:2009 biological<br>evaluation of medical devices<br>- part 5, tests for in vitro<br>cytotoxicity. | To evaluate the in vitro<br>cytotoxic potential of the test<br>item (both inner and outer<br>surface) Extracts in L-929<br>mouse fibroblasts cells using<br>elution method. | Under the conditions<br>of study non cytotoxic | Under the conditions<br>of the study.<br>cytotoxic.<br>Additional testing<br>was performed to<br>determine if this<br>was a systemic<br>toxicity concern. |
| ISO 10993-11:2017 biological<br>evaluation of medical devices<br>- part 11, tests for systemic<br>toxicity. | To determine the acute<br>systemic toxicity potential of<br>the test item extracts (both<br>inside and outer surfaces) in<br>swiss Albino mice. | Under the conditions<br>of study the device<br>extracts do not<br>pose a systemic<br>toxicity concern | Under the conditions<br>of study the device<br>extracts do not<br>pose a<br>systemic<br>toxicity concern |

#### 8. Discussion of Clinical Tests Performed:

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

#### 9. Conclusions:

The conclusions drawn from the nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed predicate device.