(238 days)
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.
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:
Hycare Touch Latex Examination Gloves: Latex examination gloves non-sterile powder-free polymer coated (Ambidextrous) – palm textured, Color: Natural white, Sizes: XS, S, M, L, XL
Hycare Med+ Nitrile Examination Gloves: Nitrile examination gloves non-sterile powder-free (Ambidextrous) - Finger textured, Color: Blue, Sizes: S, M, L, XL, XXL
This is a 510(k) premarket notification for medical gloves, specifically "Hycare Med+ Nitrile Examination Gloves" and "Hycare Touch Latex Examination Gloves." The document describes non-clinical testing performed to demonstrate substantial equivalence to predicate devices. Clinical performance testing was explicitly stated as "N/A Not applicable for this device."
Therefore, this response will focus on the non-clinical testing results as they relate to acceptance criteria.
1. Table of Acceptance Criteria and Reported Device Performance
Let's present the tables for each device separately.
Device Candidate #1: Hycare Med+ Nitrile Examination Gloves
| Test Title | Acceptance Criteria | Reported Device Performance | Met Acceptance Criteria? |
|---|---|---|---|
| ASTM D6319-10 Standard Specification for Nitrile Examination Gloves for Medical Application | |||
| Tensile Strength (Physical Properties) | Before Aging: 14 MPa min; After Aging: 14 MPa min | Met acceptance criteria after Aging at 70°C for 168 hrs @ 100°C for 22 hrs | Yes |
| Elongation (Physical Properties) | Before Aging: 500% Elongation min; After Aging: 400% Elongation min | Met acceptance criteria after Aging at 70°C for 168 hrs @ 100°C for 22 hrs | Yes |
| ASTM D5151 Standard Test Method for detection of Holes in Medical Gloves | Inspection level G-1, AQL 2.5, reject max of 22 samples | 19 rejects detected, under 22 by AQL standards | Yes |
| D6124-06 Standard Test Method for Residual Powder on Medical Gloves | Residue limit < 2.0 mg on all sizes | All powder residue on all sizes was < 2.0mg | Yes |
| ISO 10993-10 Biological evaluation on medical device Part 10: Test for irritation and Skin Sensitization | Sensitization: Grades of <1, no evidence of sensitization; Skin Irritation: Test sites should not exceed control site grade | Grade 0 for all tests | Yes |
| ISO 10993-5 Biological evaluation of medical devices - Part 5: Tests for In Vitro cytotoxicity | Cytotoxicity Grade < 2 at undiluted extraction; Non-Toxic to L-929 cells | Cytotoxic at undiluted extraction | No (Failed) |
| ISO 10993-11 Biological Evaluation of Medical Devices - Part 11, Tests for Systemic Toxicity | 1. No significantly greater biological reactivity than solvent control. 2. No significant loss of body weight > 10% in control. 3. No mortality or abnormal behavior in control. | No mortality or morbidity observed, gradual increase in body weight and no signs of ill health or toxicity was observed | Yes |
Device Candidate #2: Hycare Touch Latex Examination Gloves
| Test Title | Acceptance Criteria | Reported Device Performance | Met Acceptance Criteria? |
|---|---|---|---|
| ASTM D3578-19 Standard Specification for Rubber Examination Gloves | |||
| Tensile Strength (Physical Properties) | Before Aging: 18 MPa min; After Aging: 14 MPa min | Met acceptance criteria after Aging at 70°C for 168 hrs @ 100°C for 22 hrs | Yes |
| Elongation (Physical Properties) | Before Aging: 650% Elongation min; After Aging: 500% Elongation min | Met acceptance criteria after Aging at 70°C for 168 hrs @ 100°C for 22 hrs | Yes |
| Stress at 500% Elongation | 5.5 MPa max | Met acceptance criteria after Aging at 70°C for 168 hrs @ 100°C for 22 hrs | Yes |
| ASTM D5151 Standard Test Method for detection of Holes in Medical Gloves | Inspection level G-1, AQL 2.5 | 13 rejects detected, under 22 by AQL standards | Yes |
| D6124-06 Standard Test Method for Residual Powder on Medical Gloves | Residue limit < 2.0 mg on all sizes | All powder residue on all sizes was < 2.0mg | Yes |
| ISO 10993-10 Biological evaluation on medical device Part 10: Test for irritation and Skin Sensitization | Sensitization: Grades of <1, no evidence of sensitization; Skin Irritation: Test sites should not exceed control site grade | Grade 0 for all tests | Yes |
| ISO 10993-5 Biological evaluation of medical devices - Part 5: Tests for In Vitro cytotoxicity | Cytotoxicity Grade < 2 at undiluted extraction; Non-Toxic to L-929 cells | Cytotoxic at undiluted extraction | No (Failed) |
| ISO 10993-11 Biological Evaluation of Medical Devices - Part 11, Tests for Systemic Toxicity | 1. No significantly greater biological reactivity than solvent control. 2. No significant loss of body weight > 10% in control. 3. No mortality or abnormal behavior in control. | No mortality or morbidity observed, gradual increase in body weight and no signs of ill health or toxicity was observed | Yes |
Note About ISO 10993-5 Cytotoxicity: Both devices "failed" the cytotoxicity test, meaning they were cytotoxic at undiluted extraction. However, the FDA's "Comments" section for both devices states "Different" for this characteristic when comparing to the predicate, with the predicate often not having conducted this specific testing. This suggests that the FDA accepted the submission despite this finding, likely based on the overall safety profile, established use of similar materials, or the specific application of the device (e.g., short-term skin contact).
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state the exact sample sizes for each test set (e.g., number of gloves tested for physical properties, number of animals for biocompatibility tests). However, for the Freedom from Pinholes (ASTM D5151) test, it mentions:
- Hycare Med+ Nitrile Examination Gloves: 19 rejects detected, under 22 by AQL standards. (This implies a sample size that would yield an AQL of 2.5 and an inspection level of G-1, allowing for a maximum of 22 defects for acceptance).
- Hycare Touch Latex Examination Gloves: 13 rejects detected, under 22 by AQL standards. (Similarly implies a sample size based on AQL 2.5, inspection level G-1).
The data provenance (country of origin of the data, retrospective or prospective) is not explicitly stated. The submitting company, Hycare International Co., Ltd., is located in Thailand, which suggests the testing may have been conducted there or by affiliated labs. The testing appears to be prospective as it's part of a submission for a new device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable and not provided in the document. The tests performed are standardized, objective physical and chemical tests (e.g., tensile strength, pinholes, residual powder) and in vitro or in vivo biocompatibility tests, which do not typically involve human expert consensus for "ground truth" in the way a diagnostic imaging AI would.
4. Adjudication Method for the Test Set
Not applicable. The tests are scientific measurements or biological assays with specific pass/fail criteria from the standards, not subjective assessments requiring adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not a comparative effectiveness study involving human readers or AI. It is a premarket notification for general medical gloves.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device does not involve an algorithm or AI.
7. The Type of Ground Truth Used
The "ground truth" is established by adherence to the specified ASTM and ISO international standards themselves. These standards prescribe methodologies and acceptance criteria for various physical, chemical, and biological properties. For example:
- Physical Properties (Tensile Strength, Elongation): Measured values against numerical thresholds defined in ASTM D6319-10 and ASTM D3578-19.
- Freedom from Pinholes: Statistical sampling and defect limits based on AQL (Acceptable Quality Level) defined in ASTM D5151.
- Residual Powder: Measured mass against a numerical threshold (2.0 mg/dm²) defined in D6124-06.
- Biocompatibility (Irritation, Sensitization, Systemic Toxicity): Observed biological responses in test subjects/cells against control groups or established thresholds for reactivity/toxicity, as per ISO 10993-10 and ISO 10993-11.
- Cytotoxicity: Cell viability/response against specified grading criteria in ISO 10993-5.
8. The Sample Size for the Training Set
Not applicable. There is no "training set" as this is not a machine learning or AI device.
9. How the Ground Truth for the Training Set was Established
Not applicable. As there is no training set, this question is not relevant.
{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:
- 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:
- 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 | PrimaryPredicate | Manufacturer | DocketNumber |
|---|---|---|---|
| Hycare Med+Nitrile ExaminationGloves | Powder FreeNitrile PatientExamGloves, | Tangshan ZhonghongPulin Plastic Co., Ltd | K120970 |
| Candidate #2 | PrimaryPredicate | Manufacturer | DocketNumber |
|---|---|---|---|
| Hycare TouchLatex ExaminationGloves | Powder FreeLatex ExamGlove, withProtein Labeling(50 ug/g or less) | Hycare InternationalCo., 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-freepolymer coated (Ambidextrous) – palm textured | Naturalwhite | |||
| 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+ NitrileExamination Gloves | Predicate DeviceTangshan Zhonghong PulinPlastic Co. Powder- FreeNitrile Patient ExamGlove | Comments |
|---|---|---|---|
| 510k | K211209 | K120970 | Different |
| Product Code | LZA | LZA | Same |
| Intended Use | A patient examination gloveis a disposable deviceintended for medicalpurposes that is worn on theexaminer's hands or finger toprevent contaminationbetween patient andexaminer. | A patient examination gloveis a disposable deviceintended for medicalpurposes that is worn on theexaminer's hands or finger toprevent contaminationbetween patient andexaminer. | 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 = 80mmSize M= 95mm Size L= 110mm SizeXL = 120mm XXL = 130 mmThickness at Palm(mm)Min; 0.05 mmThickness at Finger Tip(mm) Min 0.05 mm | Overall Length (mm)Min 230mm Width (±10mm) Size S = 80mmSize M= 95mm Size L= 110mm SizeXL = 120mmThickness at Palm(mm)Min; 0.05 mmThickness at Finger Tip(mm) Min 0.05 mm | Meets ASTMD6319-10 |
| PhysicalProperties | Before Ageing TensileStrength (MPa) = 14 minUltimate Elongation (%)= 500 minAfter Aging at 70°C for 168hrs @ 100°C for22 hrs Tensile Strength(MPa) = 14 min UltimateElongation (%) = 400 min | Before Ageing TensileStrength (MPa) = 14 minUltimate Elongation (%)= 500 minAfter Aging at 70°C for 168hrs @ 100°C for22 hrs Tensile Strength(MPa) = 14 min UltimateElongation (%) = 400 min | Meets ASTMD6319-10 |
| Freedom fromPinholes | AQL 2.5Inspection Level G-1 | AQL 2.5Inspection Level G-1 | Meets ASTMD5151-19 |
| Residual Powder | < 2.0 mg/dm2 | < 2.0 mg/dm2 | Meets ASTMD6124-06 |
| Biocompatibility -ISO 10993-10--Primary SkinIrritationTest | Under the conditions ofthis study, the testarticle was a nonirritant. | Under the conditions ofthis study, the testarticle was a nonirritant. | MeetsISO 10993-10 |
| ISO 10993-10-DermalSensitizationAssay | Under the conditions ofthis study, the testarticle was a non-sensitizer. | Under the conditions ofthis study, the testarticle was a non-sensitizer. | MeetsISO 10993-10 |
| ISO 10993-5Biologicalevaluation ofmedical devices --Part 5: Tests for InVitro cytotoxicity | Under the conditions of thisstudy, the test article wascytotoxic; does not meet ISO10993-5 | Did not conduct this testing | Different |
| ISO 10993-11-Systemic Toxicity | Under the conditions of thisstudy, the test article did notinduce systemic toxicity;meets ISO 10993-11 | Did not conduct this testing | Different |
| Labeling for thelegally marketeddevice to whichsubstantialequivalence isclaimed | Powder Free-Patient ExaminationGlove-Single Use Only- Manufactured For:- Lot-Blue color- Non-sterile | Powder Free-Patient ExaminationGlove-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 LatexExamination Gloves | Predicate DeviceHycare International Co., LtdPowder-Free Latex ExamGloves With Protein Labeling(50 ug/g or less | Comments |
|---|---|---|---|
| 510k | K211209 | K020042 | Different |
| Product Code | LYY | LYY | Same |
| Intended Use | A patient examination gloveis a disposable deviceintended for medicalpurposes that is worn on theexaminer's hands or finger toprevent contaminationbetween patient andexaminer. | A patient examination gloveis a disposable deviceintended for medicalpurposes that is worn on theexaminer's hands or finger toprevent contaminationbetween patient andexaminer. | 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 mmWidth (± 10 mm) Size XS =70mm Size S = 80mmSize M= 95mm Size L= 110mm SizeXL = 120 mmThickness at Palm(mm)Min; 0.08 mmThickness at Finger Tip(mm) Min 0.08 mm | Overall Length (mm)Min 220-230 mmWidth (± 10 mm) Size XS =70mm Size S = 80mmSize M= 95mm Size L= 110mm SizeXL = 120 mmThickness at Palm(mm)Min; 0.08+ mmThickness at Finger Tip(mm) Min 0.08 mm | Meets ASTMD3578-19 |
| PhysicalProperties | Before Aging TensileStrength (MPa) = 18minUltimate Elongation (%)= 650minStress at 500% elongation =max 5.5 MPaAfter Aging at 70°C for 168hrs @ 100°C for22 hrs Tensile Strength(MPa) = 14min UltimateElongation (%) = 500min | Before Aging TensileStrength (MPa) = 18minUltimate Elongation (%)= 650minStress at 500% elongation =max 5.5 MPaAfter Aging at 70°C for 168hrs @ 100°C for22 hrs Tensile Strength(MPa) = 14min UltimateElongation (%) = 500min | Meets ASTMD3578-19 |
| Freedom fromPinholes | AQL 2.5Inspection Level G-1 | AQL 2.5Inspection Level G-1 | Meets ASTMD5151-19 |
| Residual Powder | < 2.0 mg/dm² | < 2.0 mg/dm² | Meets ASTMD6124-06 |
| Biocompatibility -ISO 10993-10--Primary SkinIrritationTest | Under the conditions ofthis study, the testarticle was a nonirritant. | Under the conditions ofthis study, the testarticle was a nonirritant. | MeetsISO 10993-10 |
| ISO 10993-10-DermalSensitizationAssay | Under the conditions ofthis study, the testarticle was a non-sensitizer. | Under the conditions ofthis study, the testarticle was a non-sensitizer. | MeetsISO 10993-10 |
| ISO 10993-5Biologicalevaluation ofmedical devices --Part 5: Tests for InVitro cytotoxicity | Under the conditions of thisstudy, the test article wascytotoxic; does not meet ISO10993-5 | Did not conduct this testing | Different |
| ISO 10993-11-Systemic Toxicity | Under the conditions of thisstudy, the test article did notinduce systemic toxicity;meets ISO 10993-11 | Did not conduct this testing | Different |
| Labeling for thelegally marketeddevice to whichsubstantialequivalence isclaimed | Powder Free-Patient ExaminationGlove-Single Use Only- Manufactured For:- Lot-Natural White- Non-sterile | Powder Free-Patient ExaminationGlove-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 D6319-10StandardSpecification forNitrile ExaminationGloves for MedicalApplication | To determinetensile strengthand elongation ofgloves | Before Aging: 14 MPa minTensile, 500% ElongationAfter Aging: 14 MPa minTensile, 400% Elongation | Metacceptancecriteria afterAging at70°C for168 hrs @100°C for22 hrs, Pass |
| ASTM D5151Standard TestMethod for detectionof Holes in MedicalGloves | Pinhole testingwith limitednumber ofrejections toensure physicalstrength | Inspection level G-1, AQL2.5, reject max of 22samples | 19 rejectsdetected,under 22 byAQLstandards,Pass |
| D6124-06 StandardTest Method forResidual Powder onMedical Gloves | To determineresidual powder ongloves to ensureunder 2.0 mg limit | Residue limit < 2.0 mg onall sizes | All powderresidue onall sizeswas <2.0mg, Pass |
| ISO 10993-10Biological evaluationon medical devicePart 10: Test forirritation and SkinSensitization | To determineirritation and skinsensitizationreactions if any | Sensitization: Grades of<1, no evidence ofsensitizationSkin Irritation: Test sitesshould not exceed controlsite grade | Grade 0 forall tests,Pass |
| ISO 10993-5Biological evaluationof medical devices -Part 5: Tests for InVitro cytotoxicity | To determine iftext article iscytotoxic | Cytotoxicity Grade < 2 atundiluted extractionNon-Toxic to L-929 cells | Cytotoxic atundilutedextraction,Failed |
{11}------------------------------------------------
| Test Title | Purpose of Test | Acceptance Criteria | Results |
|---|---|---|---|
| BiologicalEvaluation ofMedical Devices -Part 11, Tests forSystemic Toxicity,ISO 10993-11 | To determine iftest article doesnot inducesystemic toxicity | 1. None of the animalstreated with test itemshould show a significantlygreater biological reactivitythan animals treated withsolvent control.2. None of the animals inthe control group shouldshow significant loss ofbody weight greater than10%.3. No mortality or abnormalbehavior such asconvulsions or prostrationshould occur in controlgroup animals. | No mortalityor morbidityobserved,gradualincrease inbody weightand nosigns of illhealth ortoxicity wasobserved,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 D3578-19StandardSpecification forRubber ExaminationGloves | To determinetensile strengthand elongation ofgloves | Before Aging: 18 MPa minTensile, 650% Elongation,5.5 MPa max at 500%ElongationAfter Aging: 14 MPa minTensile, 500% Elongation | Metacceptancecriteria afterAging at70oC for168 hrs @100oC for22 hrs, Pass |
| ASTM D5151Standard TestMethod for detectionof Holes in MedicalGloves | Pinhole testingwith limitednumber ofrejections toensure physicalstrength | Inspection level G-1, AQL2.5 | 13 rejectsdetected,under 22 byAQLstandards,Pass Pass |
| D6124-06 StandardTest Method forResidual Powder onMedical Gloves | To determineresidual powder ongloves to ensureunder 2.0 mg limit | Residue limit < 2.0 mg onall sizes | All powderresidue onall sizeswas <2.0mg, Pass |
{12}------------------------------------------------
| Test Title | Purpose of Test | Acceptance Criteria | Results |
|---|---|---|---|
| ISO 10993-10Biological evaluationon medical devicePart 10: Test forirritation and SkinSensitization | To determineirritation and skinsensitizationreactions if any | Sensitization: Grades of<1, no evidence ofsensitizationSkin Irritation: Test sitesshould not exceed controlsite grade | Grade 0 forall tests,Pass |
| ISO 10993-5Biological evaluationof medical devices -Part 5: Tests for InVitro cytotoxicity | To determine iftext article iscytotoxic | Cytotoxicity Grade <2 atundiluted extractionNon-Toxic to L-929 cells | Cytotoxic atundilutedextraction,Failed |
| BiologicalEvaluation ofMedical Devices -Part 11, Tests forSystemic Toxicity,ISO 10993-11 | To determine iftest article doesnot inducesystemic toxicity | 1. None of the animalstreated with test itemshould show a significantlygreater biological reactivitythan animals treated withsolvent control.2. None of the animals inthe control group shouldshow significant loss ofbody weight greater than10%.3. No mortality or abnormalbehavior such asconvulsions or prostrationshould occur in controlgroup animals. | No mortalityor morbidityobserved,gradualincrease inbody weightand nosigns of illhealth ortoxicity wasobserved,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.
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.