← Product Code [LYY](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYY) · K212438 # Comfortpro (K212438) _Thai Rubber Industry Company Limited · LYY · Dec 7, 2021 · General Hospital · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYY/K212438 ## Device Facts - **Applicant:** Thai Rubber Industry Company Limited - **Product Code:** [LYY](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYY.md) - **Decision Date:** Dec 7, 2021 - **Decision:** SESE - **Submission Type:** Abbreviated - **Regulation:** 21 CFR 880.6250 - **Device Class:** Class 1 - **Review Panel:** General Hospital ## Indications for Use Comfortpro latex examination powder free gloves is disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. ## Device Story Comfortpro is a disposable, non-sterile, powder-free natural rubber latex examination glove. It is worn by healthcare examiners to provide a barrier against contamination between the patient and the examiner. The device is used in clinical or medical settings. It functions as a physical barrier. The healthcare provider dons the glove manually before patient interaction. The device benefits the patient and provider by reducing the risk of cross-contamination during medical examinations. ## Clinical Evidence No clinical data. Bench testing only. Performance verified against ASTM D3578-19 (dimensions, physical properties), ASTM D5151-19 (water-tightness/holes), ASTM D6124-06 (residual powder), and ASTM D5712-15 (extractable protein). Biocompatibility testing performed per ISO 10993-10 (irritation/sensitization), ISO 10993-5 (cytotoxicity), and ISO 10993-11 (acute systemic toxicity). ## Technological Characteristics Material: Natural rubber latex. Form factor: Disposable, non-sterile, powder-free examination glove. Dimensions and physical properties (tensile strength, elongation) meet ASTM D3578-19. Biocompatibility: Complies with ISO 10993-5, 10993-10, and 10993-11. No electronic components or software. ## Regulatory 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 - Palm Care Latex Examination Powder Free Gloves ([K202377](/device/K202377.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. December 7, 2021 Thai Rubber Industry Company Limited % Manoj Zacharias Consultant Liberty Management Group Ltd. 75 Executive Dr. STE 114, Aurora, Illinois 60504 Re: K212438 Trade/Device Name: Comfortpro Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LYY Dated: November 4, 2021 Received: November 4, 2021 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, 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) K212438 Device Name Comfortpro Indications for Use (Describe) Comfortpro latex examination powder free gloves 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 801 Subpart D) X 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 PRAStaff(@fda.hhs.gov "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}------------------------------------------------ #### A. APPLICANT INFORMATION | 510(K) Owner's Name | THAI RUBBER INDUSTRY COMPANY LIMITED | |---------------------|--------------------------------------------------------------| | Address | 738 MOO 5, MANAM KOO,
PLUAKDAENG
RAYONG 21140 THAILAND | | Phone | +66-81-6298773, +66-85-6000373 | | Fax | - | | E-mail | chawalit@thairubberindustry.com | | Contact Person | Mr. Chawalit Tiyadechachai | | Designation | Owner and Managing Director | | Contact Number | +66-81-6298773, +66-85-6000373 | | Contact Email | chawalit@thairubberindustry.com,
Chawalit.tiya@gmail.com | | Date Submitted | July 15, 2021 | #### B. DEVICE IDENTIFICATION | Name of the device | COMFORTPRO | |-----------------------------------|--------------------------------------| | Product proprietary or trade name | COMFORTPRO | | Common or usualname | Latex examination powder free gloves | | Classification name | Latex Patient Examination Glove | | Device Classification | Class-1 | | Product Code | LYY | | Regulation Number | 21 CFR 880.6250 | | Review Panel | General Hospital | #### C. PREDICATE DEVICE | Predicate Device | Hi-Care Thai Gloves Co. Ltd. | |------------------|------------------------------| | 510(k) Number | K202377 | | Regulatory Class | Class 1 | | Product code | LYY | ### D. DESCRIPTION OF THE DEVICE: COMFORTPRO Latex Examination Powder Free Gloves are manufactured to meet all the current specifications listed under the ASTM Specification D3578-19, Standard Specification for Rubber Examination Gloves. They are made from Natural Rubber Latex. These gloves are Natural in color (No color added) and are powder free. {4}------------------------------------------------ #### E. INDICATIONS FOR USE OF THE DEVICE: COMFORTPRO latex examination powder free gloves is disposable device intended for medical purpose that is 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 | | Comparison | | |------------------------------------------|--------------|-----------------------------------------------------------------------------------------------|----------------------------------------------------|-----------------|---------| | | | PREDICATE | CURRENT | | | | 510(k) Number | -- | K202377 | K212438 | | | | Name of device | -- | Palm Care Latex
Examination Powder
Free Gloves | ComfortPro latex Examination
Powder Free Gloves | -- | | | Dimensions- Length | ASTMD3578-19 | Length > 230 mm | Length > 230 mm | Similar | | | | | | Size | Average | | | | | | X-Small | 245 mm | | | | | | Small | 238 mm | | | | | | Medium | 233 mm | | | | | | Large | 240 mm | | | Dimensions- Width | ASTMD3578-19 | Width Min 95+/- 10
mm (for medium
size) | Width Min 95+/-10
mm (for medium size) | Similar | | | | | | Size | Average | | | | | | X-Small | 77 mm | | | | | | Small | 81 mm | | | | | | Medium | 93 mm | | | | | | Large | 101 mm | | | Physical Properties-
Tensile Strength | ASTMD3578-19 | Before Ageing
Tensile Strength
> 18 Mpa After
Ageing Tensile
Strength
> 14 Mpa | Before Ageing
Tensile Strength > 18 Mpa | Similar | | | | | | Size | Actual value | | | | | | X-Small | 29.6 | | | | | | Small | 25 | | | | | | Medium | 26 | | | | | | Large | 24.9 | | | | | | After Ageing
Tensile Strength > 14 Mpa | | Similar | | | | | Size | Actual
value | | | | | | X-Small | 25.5 | | | | | | Small | 24.1 | | | | | | Medium | 22.2 | | | | | | Large | 24.4 | | {5}------------------------------------------------ | CHARACTERSTICS | STANDARDS | DEVICE PERFORMANCE | | Comparison | | | | | | | | | | | | | | | | | | | | | |---------------------------------------------|---------------------------------------------------------|----------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|---------|--|--|--|--|---------| | | | PREDICATE | CURRENT | | | | | | | | | | | | | | | | | | | | | | | 510(k) Number | -- | K202377 | K212438 | | | | | | | | | | | | | | | | | | | | | | | Physical Properties-
Ultimate Elongation | ASTMD3578-19 | Before Ageing
Ultimate
Elongation
> 650%

After Ageing
Ultimate
Elongation
>500% | Before Ageing
Ultimate Elongation > 650%
Size Actual value X-Small 810 Small 760 Medium 680 Large 780
After Ageing
Ultimate Elongation > 500% Size Actual value X-Small 820 Small 760 Medium 650 Large 760 | | | | | | | | | | | | | | | | | | | | | Similar | | Thickness | ASTMD3578-19 | Palm > 0.08 mm
Finger > 0.08 mm | Palm > 0.08 mm
Finger > 0.08 mm Size Palm (Actual value) Finger (Actual value) X-Small 0.102 mm. 0.114 mm. Small 0.087 mm. 0.109 mm. Medium 0.10 mm. 0.122 mm. Large 0.108 mm. 0.121 mm. | | | | | | | | | | | | | | | | Similar | | | | | | | Powder Free Residue | ASTMD3578-19 | $\leq$ 2 mg/glove | 0.68 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) | Under the
conditions
of the study, non-
cytotoxic | Under the conditions of the
study, non-cytotoxic | Same | | | | | | | | | | | | | | | | | | | | | | | Acute Systemic
Toxicity Test ISO
10993-11:2017(E) | 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 | same | | | | | | | | | | | | | | | | | | | | | {6}------------------------------------------------ | CHARACTERSTICS | STANDARDS | DEVICE PERFORMANCE | | COMPARISON
ON | |-----------------------|--------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------| | | | PREDICATE | CURRENT | | | 510(k) Number | | K202377 | K212438 | | | Water Tight (1000 ml) | ASTM D5151-19
AQL-2.5 | Passes | Passes | Similar | | Indication for 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. | ComfortPro latex
examination powder free
gloves is disposable
device intended for
medical purpose that is
worn on the examiner's
hand to prevent
contamination
between patient and
examiner. | Same | | Material | | Natural Latex | Natural Latex | Identical | | Color | | Natural (No color is added) | Natural color (No color is
added) | Similar | | Size | ASTMD3578-19 | X Small, Small, Medium,
Large | X Small, Small,
Medium, Large | Similar | | Single Use | Medical Glove
Guidance
Manual-
Labeling | Single Use | Single Use | Same | | Sterile/nonsterile | | Nonsterile | Nonsterile | 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) | | Hi-Care Thai Gloves Co.
Ltd. | THAI RUBBER
INDUSTRY COMPANY
LIMITED | --- | Both devices meet the ASTM standard D3578. {7}------------------------------------------------ ## G. COMPARISON BASED ON AN ASSESSMENT OF NON-CLINICAL PERFORMANCE DATA ### BENCH TEST DATA | TEST METHOD | PURPOSE | ACCEPTANCE CRITERIA | RESULT | | | | | | | | | | | | | | | | |--------------------------------------------------------------------------------|--------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--| | ASTM D3578-19
Standard
Specification for
Rubber Examination
Gloves | To determine the
length of the gloves | Min 230 mm for all
sizes | X-Small : 245 mm
Small : 238 mm
Medium : 233 mm
Large : 240 mm | | | | | | | | | | | | | | | | | ASTM D3578-19
Standard
Specification for
Rubber Examination
Gloves | To determine the
width of the gloves | X-Small : 70+/-10 mm
Small : 80+/-10 mm
Medium : 95+/-10 mm
Large : 111+/-10 mm | X-Small : 77 mm
Small : 81 mm
Medium : 93 mm
Large : 101 mm | | | | | | | | | | | | | | | | | ASTM D3578-19
Standard
Specification for
Rubber Examination
Gloves | To determine the
thickness of the
gloves | Palm
0.08 mm min for all
sizes
Finger
0.08 mm min for all
sizes | Size Palm Finger X-Small 0.102 mm 0.114 mm Small 0.087 mm 0.109 mm Medium 0.10 mm 0.122 mm Large 0.108 mm 0.121 mm | | | | | | | | | | | | | | | | | ASTM D3578-19
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 Before
ageing After
ageing X-Small 29.6 MPa 25.5 MPa Small 25 MPa 24.1 MPa Medium 26 MPa 22.2 MPa Large 24.9 MPa 24.4 MPa | | | | | | | | | | | | | | | | | | 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 Before
ageing After
ageing X-Small 810% 820% Small 760% 760% Medium 680% 650% Large 780% 760% | | | | | | | | | | | | | | | | {8}------------------------------------------------ | TEST METHOD | PURPOSE | ACCEPTANCE
CRITERIA | RESULT | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------|------------------------|------------------------| | ASTM D5151-19 Standard
Test Method for Detection
of Holes in Medical Gloves | To determine the holes
in the gloves | AQL 2.5 | Gloves Passes AQL 2.5 | | 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 | Medium : 0.68 mg/glove | | ASTM D5712-15
(Reapproved 2020) Standard
Test Method for Analysis of
Aqueous Extractable Protein
in Latex, Natural Rubber, and
Elastomeric Products Using
the Modified Lowry Method | To determine the
extractable protein in
the gloves. | 200 µg/ dm² Max | Medium : 187.1 µg/ dm² | ### BIOCOMPATIBILITY DATA | TEST METHOD | PURPOSE | ACCEPTANCE
CRITERIA | RESULT | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | ISO 10993-10:2010(E)
Biological Evaluation Of
Medical Devices - Part 10,
Tests for Irritation and Skin
Sensitization.
Test done for irritation. | To evaluate the test
item, for skin irritation
test in New Zealand
White rabbits. | Under the condition
of study, not an
irritant | Under the condition of
study, not an irritant | | ISO 10993 10:2010(E)
Biological Evaluation of
Medical Devices - Part 10,
Tests for Irritation and Skin
Sensitization.
Test done for skin sensitization | To evaluate the test
item, for the skin
sensitization in Guinea
pigs by maximization
test. | Under the conditions
of the study, not a
sensitizer | Under the conditions of
the study, not a
sensitizer | | ISO10993-5:2009(E)
Biological Evaluation of
Medical Devices - Part 5,
Tests for In Vitro
Cytotoxicity. | To evaluate the test
item, for its ability to
induce cytotoxicity
using L-929 mouse
fibroblast cells by
Elution Method. | Under the conditions
of the study, non-
cytotoxic | Under the conditions of the
study cytotoxic for 100%
(neat) test item extract. As
a follow up, acute
systemic toxicity testing
was performed to
demonstrate the extract
did not present an acute
systemic toxicity concern. | | ISO 10993-11:2017(E)
Biological Evaluation of
Medical Devices - Part 11,
Tests for Systemic Toxicity. | To evaluate the test
item, for acute systemic
toxicity 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 | {9}------------------------------------------------ # 510(K) SUMMARY #### AS REQUIRED BY: 21CFR§807.92(C) The performance test data of the non-clinical tests meet following standards: ASTM D3578-19 Standard Specification for Rubber Examination Gloves ASTM D5151-19 Standard Test Method for Detection of Holes in Medical Gloves ASTM D6124-06 (Reapproved 2017) Standard Test Method for Residual Powder on Medica1Gloves ASTM D5712-15 (Reapproved 2020) Standard Test Method for Analysis of Aqueous Extractable Protein in Latex, Natural Rubber, and Elastomeric Products Using the Modified Lowry Method ISO 10993-10:2010 (E)Biological Evaluation of Medical Devices - Part 10, Tests for Irritation and Skin Sensitization. ISO 10993-5:2009(E) Biological Evaluation of Medical Devices - Part 5, Tests for In Vitro Cytotoxicity. ISO 10993-11:2017 (E) Biological Evaluation of Medical Devices - Part 11, Tests for Systemic Toxicity. #### H. COMPARISON BASED ON ASSESSMENT OF CLINICAL PERFORMANCE DATA Not applicable - Clinical data is not needed for gloves or for most devices cleared by the 510(k) process. #### I. CONCLUSION The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission ComfortPro Latex Examination Powder Free Gloves is as safe, as effective, and performs as well as or better than the legally marketed predicate device K202377. --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYY/K212438](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LYY/K212438) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com