← Product Code [LZA](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LZA) · K211209 # Hycare Med+ Nitrile Examination Gloves; Hycare Touch Latex Examination Gloves (K211209) _Hycare International Co., Ltd. · LZA · Dec 17, 2021 · General Hospital · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LZA/K211209 ## Device Facts - **Applicant:** Hycare International Co., Ltd. - **Product Code:** [LZA](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LZA.md) - **Decision Date:** Dec 17, 2021 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.6250 - **Device Class:** Class 1 - **Review Panel:** General Hospital ## Indications for Use A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner. ## Device Story Disposable, non-sterile examination gloves; available in nitrile (Hycare Med+) and latex (Hycare Touch) variants. Used by healthcare personnel to provide a physical barrier against contamination between patient and examiner. Nitrile gloves are blue, finger-textured, and ambidextrous. Latex gloves are natural white, palm-textured, polymer-coated, and ambidextrous. Both types are single-use and intended for clinical settings. Devices function as passive barriers; performance verified against ASTM standards for tensile strength, elongation, and pinhole resistance. Benefit includes reduced risk of cross-contamination during medical examinations. ## Clinical Evidence No clinical data. Bench testing only. Conformance to ASTM D6319-10 (nitrile) and ASTM D3578-19 (latex) for physical properties; ASTM D5151 for pinhole detection; ASTM D6124-06 for residual powder. Biocompatibility testing per ISO 10993-10 (irritation/sensitization) and ISO 10993-11 (systemic toxicity) passed. Note: ISO 10993-5 cytotoxicity testing reported as failed/cytotoxic at undiluted extraction. ## Technological Characteristics Materials: Nitrile compound (Candidate 1) and Rubber/Latex compound (Candidate 2). Form factor: Ambidextrous, non-sterile, powder-free. Nitrile: finger-textured, blue. Latex: palm-textured, polymer-coated, natural white. Standards: ASTM D6319-10 (nitrile), ASTM D3578-19 (latex), ASTM D5151 (pinholes), ASTM D6124-06 (residual powder). Biocompatibility: ISO 10993-10, ISO 10993-11. ## 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 - Powder Free Nitrile Patient Exam Gloves ([K120970](/device/K120970.md)) - Powder-Free Latex Exam Glove, with Protein Labeling (50 ug/g or less) ([K020042](/device/K020042.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 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. December 17, 2021 Hycare International Co., Ltd Sebastian Feye Regulatory Affairs Consultant Accurate Consulting Inc. 3234 Ibis Street San Diego, California 92103 Re: K211209 Trade/Device Name: Hycare Med+ Nitrile Examination Gloves; Hycare Touch Latex Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-powdered patient examination glove Regulatory Class: Class I. reserved Product Code: LZA, LYY Dated: November 1, 2021 Received: November 4, 2021 Dear Sebastian Feye: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {1}------------------------------------------------ Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. For Clarence W. Murray, III, 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 Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. ## Indications for Use 510(k) Number (if known) K211209 Device Name Hycare Touch Latex Examination Gloves ### Indications for Use (Describe) A patient exammation glove is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner. Model LWH-0201 - Latex exammation gloves non-sterile powder-free polymer coated (Ambidextrous) - palm textured -- Color: Natural White - Sizes: X-Small, Small, Medium, Large and X-Large 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) #### 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." FORM FDA 3881 (6/20) Page 1 of 1 PSC Publishing Services (301) 443-6740 {3}------------------------------------------------ ## DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. 510(k) Number (if known) K211209 Device Name Hycare Med+ Nitrile Examination Gloves ### Indications for Use (Describe) A patient exammation glove is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner. Model NBL-0201 - Nitrile examination gloves non-sterile powder-free (Ambidextrous) - Finger textured - Color: Blue -Sizes: Small, Medium, Large, X-Large and XX Large 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) ### 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." FORM FDA 3881 (6/20) {4}------------------------------------------------ # 510(k) Summary - K211209 ## 1 SUBMITTER: Tippawan Phongpheaw, Assistant Managing Director Hycare International Co., Ltd 1197 Moo 3, Asia Highway, Khuanlang Hatyai Songkhla, 90110 Thailand Establishment Registration Number: None ## Primary Contact: Sebastian Feye, Regulatory Affairs Consultant Accurate Consultants Inc. 3234 Ibis Street San Diego, CA, 92103 Telephone: 619-517-0673 sebastian@accuratefdaconsulting.com Date Prepared: 12/16/2021 #### DEVICE: വ ## Name of Device Candidate #1: 1) Hycare Med+ Nitrile Examination Gloves Common or Usual Name: Exam Gloves Classification Name: Patient Examination Gloves (21 CFR 880.6250) Regulatory Class: 1, reserved Product code: LZA ## Name of Device Candidate #2: 2) Hycare Touch Latex Examination Gloves Common or Usual Name: Exam Gloves Classification Name: Patient Examination Gloves (21 CFR 880.6250) Regulatory Class: 1, reserved {5}------------------------------------------------ #### ന PREDICATE DEVICES: | Candidate #1 | Primary
Predicate | Manufacturer | Docket
Number | |----------------------------------------------|---------------------------------------------------|----------------------------------------------|------------------| | Hycare Med+
Nitrile Examination
Gloves | Powder Free
Nitrile Patient
Exam
Gloves, | Tangshan Zhonghong
Pulin Plastic Co., Ltd | K120970 | | Candidate #2 | Primary
Predicate | Manufacturer | Docket
Number | |---------------------------------------------|-----------------------------------------------------------------------------------|----------------------------------|------------------| | Hycare Touch
Latex Examination
Gloves | Powder Free
Latex Exam
Glove, with
Protein Labeling
(50 ug/g or less) | Hycare International
Co., Ltd | K020042 | #### DEVICE DESCRIPTION: 4. Two subject devices are bundled into this 510(k) submission. The first is a Hycare Med+ Nitrile Examination Gloves, blue colored, non-sterile called Hycare Med+ Nitrile Examination Gloves and the second is Hycare Touch Latex Examination Gloves, Natural White, Non-Sterile with Protein Labeling Claim (50 ug/g or less) called Hycare Touch Latex Examination Gloves. The principal operation both types of patient exam gloves are to provide single use barrier protection for the wearer and each device meets all the appropriate requirement specifications for Barrier Protection and tensile properties as defined in ASTM D6319-10, Standard Specification for Nitrile Examination Gloves and ASTM D3578-19, Standard Specification for Rubber Examination Gloves. The following models are disposable, single-use examination gloves (in boxes of 50, 100 and 200) which are included in this submission: | Models | Description | Length | Color | Sizes | |--------|-------------|--------|-------|-------| |--------|-------------|--------|-------|-------| {6}------------------------------------------------ | | Hycare Touch Latex Examination Gloves | | | | |----------|---------------------------------------------------------------------------------------------------|------------|------------------|------------------| | | Latex examination gloves non-sterile powder-free
polymer coated (Ambidextrous) – palm textured | | Natural
white | | | LWH-0201 | | min 240 mm | | XS,S,M,L,XL | | | Hycare Med+ Nitrile Examination Gloves | | | | | | Nitrile examination gloves non-sterile powder-free
(Ambidextrous) - Finger textured | | Blue | S,M,L,XL,
XXL | | NBL-0201 | | min 240 mm | | | #### 5 INDICATIONS FOR USE: A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner. ### 6 COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE: The following tables compares each subject device and it's predicate device, that are identified in Section 3.0 of this summary: ## Candidate #1 | Characteristics | Subject device,
Hycare Med+ Nitrile
Examination Gloves | Predicate Device
Tangshan Zhonghong Pulin
Plastic Co. Powder- Free
Nitrile Patient Exam
Glove | Comments | |----------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------| | 510k | K211209 | K120970 | Different | | Product Code | LZA | LZA | Same | | Intended Use | A patient examination glove
is a disposable device
intended for medical
purposes that is worn on the
examiner's hands or finger to
prevent contamination
between patient and
examiner. | A patient examination glove
is a disposable device
intended for medical
purposes that is worn on the
examiner's hands or finger to
prevent contamination
between patient and
examiner. | Same | | Material Use | Nitrile Compound | Nitrile Compound | Same | | Color | Blue | Blue | Same | | Sterility | Non-sterile | Non-sterile | Same | | Dimensions | Overall Length (mm)
Min 230mm Width (±
10mm) Size S = 80mm
Size M= 95mm Size L
= 110mm Size
XL = 120mm XXL = 130 mm
Thickness at Palm
(mm)
Min; 0.05 mm
Thickness at Finger Tip
(mm) Min 0.05 mm | Overall Length (mm)
Min 230mm Width (±
10mm) Size S = 80mm
Size M= 95mm Size L
= 110mm Size
XL = 120mm
Thickness at Palm
(mm)
Min; 0.05 mm
Thickness at Finger Tip
(mm) Min 0.05 mm | Meets ASTM
D6319-10 | | Physical
Properties | Before Ageing Tensile
Strength (MPa) = 14 min
Ultimate Elongation (%)
= 500 min
After Aging at 70°C for 168
hrs @ 100°C for
22 hrs Tensile Strength
(MPa) = 14 min Ultimate
Elongation (%) = 400 min | Before Ageing Tensile
Strength (MPa) = 14 min
Ultimate Elongation (%)
= 500 min
After Aging at 70°C for 168
hrs @ 100°C for
22 hrs Tensile Strength
(MPa) = 14 min Ultimate
Elongation (%) = 400 min | Meets ASTM
D6319-10 | | Freedom from
Pinholes | AQL 2.5
Inspection Level G-1 | AQL 2.5
Inspection Level G-1 | Meets ASTM
D5151-
19 | | Residual Powder | < 2.0 mg/dm2 | < 2.0 mg/dm2 | Meets ASTM
D6124-
06 | | Biocompatibility -
ISO 10993-10-
-Primary Skin
Irritation
Test | Under the conditions of
this study, the test
article was a nonirritant. | Under the conditions of
this study, the test
article was a nonirritant. | Meets
ISO 10993-10 | | ISO 10993-10-
Dermal
Sensitization
Assay | Under the conditions of
this study, the test
article was a non-sensitizer. | Under the conditions of
this study, the test
article was a non-sensitizer. | Meets
ISO 10993-10 | | ISO 10993-5
Biological
evaluation of
medical devices --
Part 5: Tests for In
Vitro cytotoxicity | Under the conditions of this
study, the test article was
cytotoxic; does not meet ISO
10993-5 | Did not conduct this testing | Different | | ISO 10993-11-
Systemic Toxicity | Under the conditions of this
study, the test article did not
induce systemic toxicity;
meets ISO 10993-11 | Did not conduct this testing | Different | | Labeling for the
legally marketed
device to which
substantial
equivalence is
claimed | Powder Free
-Patient Examination
Glove
-Single Use Only
- Manufactured For:
- Lot
-Blue color
- Non-sterile | Powder Free
-Patient Examination
Glove
-Single Use Only
- Manufactured For:
- Lot
-Blue color
- Non-sterile | Same | {7}------------------------------------------------ {8}------------------------------------------------ There are no significant differences between the Hycare International Nitrile examination gloves non-sterile powder-free and the predicate, Tangshan Zhonghong Pulin Plastic Co Powder-Free Nitrile Patient Examination Gloves. (K120970) ## Candidate #2 | Characteristics | Subject device,
Hycare Touch Latex
Examination Gloves | Predicate Device
Hycare International Co., Ltd
Powder-Free Latex Exam
Gloves With Protein Labeling
(50 ug/g or less | Comments | |----------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------| | 510k | K211209 | K020042 | Different | | Product Code | LYY | LYY | Same | | Intended Use | A patient examination glove
is a disposable device
intended for medical
purposes that is worn on the
examiner's hands or finger to
prevent contamination
between patient and
examiner. | A patient examination glove
is a disposable device
intended for medical
purposes that is worn on the
examiner's hands or finger to
prevent contamination
between patient and
examiner. | Same | | Material Use | Rubber (Latex) Compound | Rubber (Latex) Compound | Same | | Color | Natural White | Natural White | Same | | Sterility | Non-sterile | Non-sterile | Same | | Dimensions | Overall Length (mm)
Min 220-230 mm
Width (± 10 mm) Size XS =
70mm Size S = 80mm
Size M= 95mm Size L
= 110mm Size
XL = 120 mm
Thickness at Palm
(mm)
Min; 0.08 mm
Thickness at Finger Tip
(mm) Min 0.08 mm | Overall Length (mm)
Min 220-230 mm
Width (± 10 mm) Size XS =
70mm Size S = 80mm
Size M= 95mm Size L
= 110mm Size
XL = 120 mm
Thickness at Palm
(mm)
Min; 0.08+ mm
Thickness at Finger Tip
(mm) Min 0.08 mm | Meets ASTM
D3578-19 | | Physical
Properties | Before Aging Tensile
Strength (MPa) = 18min
Ultimate Elongation (%)
= 650min
Stress at 500% elongation =
max 5.5 MPa
After Aging at 70°C for 168
hrs @ 100°C for
22 hrs Tensile Strength
(MPa) = 14min Ultimate
Elongation (%) = 500min | Before Aging Tensile
Strength (MPa) = 18min
Ultimate Elongation (%)
= 650min
Stress at 500% elongation =
max 5.5 MPa
After Aging at 70°C for 168
hrs @ 100°C for
22 hrs Tensile Strength
(MPa) = 14min Ultimate
Elongation (%) = 500min | Meets ASTM
D3578-19 | | Freedom from
Pinholes | AQL 2.5
Inspection Level G-1 | AQL 2.5
Inspection Level G-1 | Meets ASTM
D5151-
19 | | Residual Powder | < 2.0 mg/dm² | < 2.0 mg/dm² | Meets ASTM
D6124-
06 | | Biocompatibility -
ISO 10993-10-
-Primary Skin
Irritation
Test | Under the conditions of
this study, the test
article was a nonirritant. | Under the conditions of
this study, the test
article was a nonirritant. | Meets
ISO 10993-10 | | ISO 10993-10-
Dermal
Sensitization
Assay | Under the conditions of
this study, the test
article was a non-sensitizer. | Under the conditions of
this study, the test
article was a non-sensitizer. | Meets
ISO 10993-10 | | ISO 10993-5
Biological
evaluation of
medical devices --
Part 5: Tests for In
Vitro cytotoxicity | Under the conditions of this
study, the test article was
cytotoxic; does not meet ISO
10993-5 | Did not conduct this testing | Different | | ISO 10993-11-
Systemic Toxicity | Under the conditions of this
study, the test article did not
induce systemic toxicity;
meets ISO 10993-11 | Did not conduct this testing | Different | | Labeling for the
legally marketed
device to which
substantial
equivalence is
claimed | Powder Free
-Patient Examination
Glove
-Single Use Only
- Manufactured For:
- Lot
-Natural White
- Non-sterile | Powder Free
-Patient Examination
Glove
-Single Use Only
- Manufactured For:
- Lot
-Natural White
- Non-sterile | Same | {9}------------------------------------------------ There are no differences between the Hycare Touch Latex Examination Gloves and the predicate device, Hycare International Co., Ltd Powder-Free Latex Exam Gloves with Protein Labeling (50 ug/g or less (K020042). {10}------------------------------------------------ #### SUMMARY OF NON-CLINICAL TESTING RESULTS 7 Candidate #1 Hycare Med+ Nitrile Examination Gloves was tested and conformed to the following standards: | Test Title | Purpose of Test | Acceptance Criteria | Results | |-------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------| | ASTM D6319-10
Standard
Specification for
Nitrile Examination
Gloves for Medical
Application | To determine
tensile strength
and elongation of
gloves | Before Aging: 14 MPa min
Tensile, 500% Elongation
After Aging: 14 MPa min
Tensile, 400% Elongation | Met
acceptance
criteria after
Aging at
70°C for
168 hrs @
100°C for
22 hrs, Pass | | ASTM D5151
Standard Test
Method for detection
of Holes in Medical
Gloves | Pinhole testing
with limited
number of
rejections to
ensure physical
strength | Inspection level G-1, AQL
2.5, reject max of 22
samples | 19 rejects
detected,
under 22 by
AQL
standards,
Pass | | D6124-06 Standard
Test Method for
Residual Powder on
Medical Gloves | To determine
residual powder on
gloves to ensure
under 2.0 mg limit | Residue limit < 2.0 mg on
all sizes | All powder
residue on
all sizes
was <
2.0mg, Pass | | ISO 10993-10
Biological evaluation
on medical device
Part 10: Test for
irritation and Skin
Sensitization | To determine
irritation and skin
sensitization
reactions if any | Sensitization: Grades of
<1, no evidence of
sensitization
Skin Irritation: Test sites
should not exceed control
site grade | Grade 0 for
all tests,
Pass | | ISO 10993-5
Biological evaluation
of medical devices -
Part 5: Tests for In
Vitro cytotoxicity | To determine if
text article is
cytotoxic | Cytotoxicity Grade < 2 at
undiluted extraction
Non-Toxic to L-929 cells | Cytotoxic at
undiluted
extraction,
Failed | {11}------------------------------------------------ | Test Title | Purpose of Test | Acceptance Criteria | Results | |--------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Biological
Evaluation of
Medical Devices -
Part 11, Tests for
Systemic Toxicity,
ISO 10993-11 | To determine if
test article does
not induce
systemic toxicity | 1. None of the animals
treated with test item
should show a significantly
greater biological reactivity
than animals treated with
solvent control.
2. None of the animals in
the control group should
show significant loss of
body weight greater than
10%.
3. No mortality or abnormal
behavior such as
convulsions or prostration
should occur in control
group animals. | No mortality
or morbidity
observed,
gradual
increase in
body weight
and no
signs of ill
health or
toxicity was
observed,
Passed | ## Candidate #2 Hycare Touch Latex Examination Gloves was tested and conformed to the following standards: | Test Title | Purpose of Test | Acceptance Criteria | Results | |--------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------| | ASTM D3578-19
Standard
Specification for
Rubber Examination
Gloves | To determine
tensile strength
and elongation of
gloves | Before Aging: 18 MPa min
Tensile, 650% Elongation,
5.5 MPa max at 500%
Elongation
After Aging: 14 MPa min
Tensile, 500% Elongation | Met
acceptance
criteria after
Aging at
70oC for
168 hrs @
100oC for
22 hrs, Pass | | ASTM D5151
Standard Test
Method for detection
of Holes in Medical
Gloves | Pinhole testing
with limited
number of
rejections to
ensure physical
strength | Inspection level G-1, AQL
2.5 | 13 rejects
detected,
under 22 by
AQL
standards,
Pass Pass | | D6124-06 Standard
Test Method for
Residual Powder on
Medical Gloves | To determine
residual powder on
gloves to ensure
under 2.0 mg limit | Residue limit < 2.0 mg on
all sizes | All powder
residue on
all sizes
was <
2.0mg, Pass | {12}------------------------------------------------ | Test Title | Purpose of Test | Acceptance Criteria | Results | |-------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------| | ISO 10993-10
Biological evaluation
on medical device
Part 10: Test for
irritation and Skin
Sensitization | To determine
irritation and skin
sensitization
reactions if any | Sensitization: Grades of
<1, no evidence of
sensitization
Skin Irritation: Test sites
should not exceed control
site grade | Grade 0 for
all tests,
Pass | | ISO 10993-5
Biological evaluation
of medical devices -
Part 5: Tests for In
Vitro cytotoxicity | To determine if
text article is
cytotoxic | Cytotoxicity Grade <2 at
undiluted extraction
Non-Toxic to L-929 cells | Cytotoxic at
undiluted
extraction,
Failed | | Biological
Evaluation of
Medical Devices -
Part 11, Tests for
Systemic Toxicity,
ISO 10993-11 | To determine if
test article does
not induce
systemic toxicity | 1. None of the animals
treated with test item
should show a significantly
greater biological reactivity
than animals treated with
solvent control.
2. None of the animals in
the control group should
show significant loss of
body weight greater than
10%.
3. No mortality or abnormal
behavior such as
convulsions or prostration
should occur in control
group animals. | No mortality
or morbidity
observed,
gradual
increase in
body weight
and no
signs of ill
health or
toxicity was
observed,
Passed | #### 8 SUMMARY OF CLINICAL PERFORMANCE TESTING: N/A Not applicable for this device. ## CONCLUSIONS: The conclusions drawn from the nonclinical tests that demonstrate that the two devices in this submission, Hycare Med+ Nitrile Examination Gloves (Candidate #1) and the Hycare Touch Latex Examination Gloves (Candidate #2) is as safe, as effective, and performs as well as or better than the legally marketed device. --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LZA/K211209](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/LZA/K211209) **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