(97 days)
No
The device description and performance studies focus on the physical properties and biocompatibility of examination gloves, with no mention of AI or ML technologies.
No.
Explanation: The device, Latex Examination Powder Free Gloves, is intended to prevent contamination and is described as a disposable device for medical purposes, not for treating a disease or condition.
No
Explanation: The "Intended Use" section clearly states that these gloves are worn to "prevent contamination between patient and examiner," not to diagnose any condition. The "Summary of Performance Studies" describes physical and biocompatibility testing, not diagnostic performance.
No
The device is a physical product (gloves) and not software. The description focuses on material properties and physical testing.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "disposable devices intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner." This describes a barrier device used for protection, not a device used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or treatment.
- Device Description: The description focuses on the physical properties and manufacturing standards of the gloves. There is no mention of reagents, calibrators, controls, or any components typically associated with in vitro diagnostic tests.
- Lack of IVD Characteristics: The document does not mention any of the key characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using chemical or biological reactions
- Measuring analytes
The device is a medical device, specifically a Class I medical device (examination glove), but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Latex Examination Powder Free Gloves are disposable devices intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Product codes (comma separated list FDA assigned to the subject device)
LYY
Device Description
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, non-sterile, ambidextrous and single use only.
Latex Examination Powder Free Gloves with sizes X-Small, Medium, Large and X-Large are included in the submission.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand
Indicated Patient Age Range
Not Found
Intended User / Care Setting
examiner
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench Test Data and Biocompatibility Data were submitted.
Bench Test Data:
- ASTM D3578-19 Standard Specification for Rubber Examination Gloves:
- To determine the length of the gloves: All sizes (X-Small, Small, Medium, Large, X-Large) met the min 230 mm criterion.
- To determine the width of the gloves: All sizes met their respective width criteria.
- To determine the thickness of the gloves: All sizes met the min 0.08 mm for palm and finger.
- To determine the physical properties - Tensile strength: All sizes met the Before Ageing (>18MPa) and After Ageing (>14MPa) criteria.
- To determine the physical properties - Ultimate Elongation: All sizes met the Before Ageing (>650%) and After Ageing (>500%) criteria.
- ASTM D5151-19 Standard Test Method for Detection of Holes in Medical Gloves: Purpose: To determine the holes in the gloves. Result: Gloves Passes AQL 2.5 (Acceptance Criteria: AQL-2.5).
- ASTM D6124-06 (Reapproved 2017) Standard Test Method for Residual Powder on Medical Gloves: Purpose: To determine the residual powder in the gloves. Result: All sizes (X-Small, Small, Medium, Large, X-Large) were ≤ 2 mg/glove (Acceptance Criteria: ≤ 2 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: Purpose: To determine the extractable protein in the gloves. Result: Medium size was 191.9 µg/dm² (Acceptance Criteria: 200 µg/dm² Max).
Biocompatibility Data:
- ISO 10993-10:2010(E) Tests for Irritation and Skin Sensitization (Irritation test): Result: Under the condition of study, not an irritant.
- ISO 10993 10:2010(E) Tests for Irritation and Skin Sensitization (Sensitization test): Result: Under the conditions of the study, not a sensitizer.
- ISO10993-5:2009(E) Tests for In Vitro Cytotoxicity: Result: Under the conditions of the study the device is "cytotoxic".
- ISO 10993-11:2017(E) Tests for Systemic Toxicity: Result: Under the conditions of study, the device extracts did not reveal any systemic toxicity.
The conclusion drawn from the nonclinical tests demonstrates that the subject devices are as safe, as effective, and performs as well as or better than the legally marketed predicate device K202377.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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 29, 2021
Thai Rubber Gloves Co., Ltd % Manoj Zacharias Consultant Liberty Management Group Ltd. 75 Executive Dr. STE 114. Aurora, Illinois 60504, USA
Re: K213073
Trade/Device Name: Latex Examination Powder Free Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Latex Exmamination Powder Free Gloves Regulatory Class: Class I. reserved Product Code: LYY Dated: November 30, 2021 Received: November 30, 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.
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 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.
For Clarence 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
Indications for Use
510(k) Number (if known) K213073
Device Name Latex Examination Powder Free Gloves
Indications for Use (Describe)
Latex Examination Powder Free Gloves are disposable devices 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)
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3
510(K) SUMMARY K213073
AS REQUIRED BY: 21CFR§807.92
A. APPLICANT INFORMATION
| 510(K) Owner's Name | THAI RUBBER GLOVES CO., LTD. |
|---|---|
| Address | 680 MOO 2 BANBUENG – KLAENG |
| RD., NONGYAI CHONBURI 20190 | |
| THAILAND. | |
| Phone | +66-2-1306356, +66-38-168613 |
| Fax | +66-2-1306357 |
| chalongkwan@thaitex.com | |
| info@thairubbergloves.com | |
| Contact Person | Miss Chalongkwan Wongsasuthikul |
| Designation | Managing Director |
| Contact Number | +66-2-1306356 |
| Contact Email | chalongkwan@thaitex.com |
| Date Submitted | 29 December 2021 |
B. DEVICE IDENTIFICATION
| Name of the device | Latex Examination Powder Free Gloves |
|---|---|
| Product proprietary or trade name | Goody Gloves / Wincare / TBG Gloves |
| Common or usual name | 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 |
| Reference Device | JR Engineering & Medical Technologies (M)
SDN.BHD. |
|------------------|-------------------------------------------------------|
| 510(k) Number | K192329 |
| Regulatory Class | Class 1 |
| Product code | LYY |
4
D. DESCRIPTION OF THE DEVICE:
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, non-sterile, ambidextrous and single use only.
Latex Examination Powder Free Gloves with sizes X-Small, Medium, Large and X-Large are included in the submission.
E. INDICATIONS FOR USE OF THE DEVICE:
Latex Examination Powder Free Gloves are disposable devices 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 | REFERENCE | SUBJECT | |||||||||||||||
| 510(k) Number | --- | K202377 | K192329 | K213073 | --- | ||||||||||||
| Name of device | --- | Palm Care Latex | |||||||||||||||
| Examination | |||||||||||||||||
| Powder Free | |||||||||||||||||
| Gloves | Blue Latex | ||||||||||||||||
| Examination | |||||||||||||||||
| Powder Free | |||||||||||||||||
| Gloves | Latex Examination | ||||||||||||||||
| Powder Free Gloves | --- | ||||||||||||||||
| Dimensions- Length | ASTM D3578-19 | Length > 230 mm | Length > 230 mm | Length > 230 mm | |||||||||||||
| Size Average X-Small 245 Small 244 Medium 247 Large 240 X-Large 247 | Similar | ||||||||||||||||
| CHARACTERSTICS | STANDARDS | DEVICE PERFORMANCE | Comparison | ||||||||||||||
| PREDICATE | REFERENCE | SUBJECT | |||||||||||||||
| 510(k) Number | K202377 | K192329 | K213073 | ||||||||||||||
| Physical Properties- | |||||||||||||||||
| Tensile Strength | ASTM D3578-19 | Before | |||||||||||||||
| Ageing | |||||||||||||||||
| Tensile | |||||||||||||||||
| Strength |
18 MPa | Before
Ageing
Tensile
Strength
18 MPa | Before Ageing
Tensile Strength
18 MPa | Similar | | | | | | | | | | | | |
| | | | | Size Ac tual
value X-Small 26.2 Small 25.0 Medium 24.0 Large 22.6 X-Large 24.2 | | | | | | | | | | | | | |
| Dimensions- Width | ASTM D3578-19 | Width Min
95+/- 10 mm
(for medium
size) | Width Min
95+/- 10 mm
(for medium
size) | Width 95+/-10 mm
(for medium size)
Size Average X-Small 77 Small 80 Medium 92 Large 101 X-Large 110 | | | | | | | | | | | | | Similar |
| | | After Ageing
Tensile
Strength
14 MPa | After Ageing
Tensile
Strength
14 MPa | After Ageing
Tensile Strength
14 MPa | Similar | | | | | | | | | | | | |
| | | | | Size Actual
value X-Small 24.1 Small 24.1 Medium 23.4 Large 24.3 X-Large 22.5 | | | | | | | | | | | | | |
| Physical Properties-
Ultimate Elongation | ASTM D3578-19 | Before
Ageing
Ultimate
Elongation
650% | Before
A geing
Ultimate
Elongation
650% | Before Ageing
Ultimate Elongation
650% | Similar | | | | | | | | | | | | |
| | | | | Size Actual
value X-Small 830 Small 790 Medium 810 Large 800 X-Large 800 | | | | | | | | | | | | | |
| | | After
Ageing
Ultimate
Elongation
500% | After A
geing
Ultimate
Elongation
500% | After Ageing
Ultimate Elongation
500% | Similar | | | | | | | | | | | | |
| | | | | Size Actual
value X-Small 800 Small 760 Medium 830 Large 810 X-Large 780 | | | | | | | | | | | | | |
5
6
| CHARACTERSTICS | STANDARDS | DEVICE PERFORMANCE | Comparison | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| PREDICATE | |||||||||||||||||||||||
| K202377 | REFERENCE | ||||||||||||||||||||||
| K192329 | SUBJECT | ||||||||||||||||||||||
| K213073 | |||||||||||||||||||||||
| 510(k) Number | |||||||||||||||||||||||
| Thickness | ASTM D3578-19 | Palm > 0.08 mm | |||||||||||||||||||||
| Finger > 0.08 mm | 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 0.115 0.125 Small 0.115 0.128 Medium 0.115 0.132 Large 0.121 0.135 X-Large 0.109 0.122 | | | | | | | | | | | | | | | | | | | Similar |
| Powder Free Residue | ASTM D3578-19 | ≤2 mg/glove | ≤2 mg/glove | ≤2 mg/glove
Size Actual value X-Small 0.60 Small 0.80 Medium 1.46 Large 0.62 X-Large 1.13 | | | | | | | | | | | | | 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 | 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 | 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,
cytotoxic
which is to be
expected as
latex is the
positive
control for this
test. | Under the conditions of
the study, cytotoxic | Similar to
reference
device | | | | | | | | | | | | | | | | | | |
| | 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 did not reveal
any systemic toxicity | Similar | | | | | | | | | | | | | | | | | | |
7
| CHARACTERSTICS | STANDARDS | DEVICE PERFORMANCE | Comparison | ||
|---|---|---|---|---|---|
| PREDICATE | REFERENCE | SUBJECT | |||
| 510(k) Number | K202377 | K192329 | K213073 | ||
| Water Tight (1000 ml) | ASTM D5151-19 | ||||
| AQL-2.5 | Passes | 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. | Blue 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. | Latex Examination | ||||
| Powder Free Gloves | |||||
| are disposable devices | |||||
| intended for medical | |||||
| purpose that is worn | |||||
| on the examiner's | |||||
| hand to prevent | |||||
| contamination | |||||
| between patient and | |||||
| examiner. | Similar | ||||
| Material | --- | Natural Latex | Natural Latex | Natural Latex | Identical |
| Color | --- | Natural (No | |||
| color is | |||||
| added) | Blue | Natural color (No | |||
| color is added) | Similar to | ||||
| predicate | |||||
| device | |||||
| Size | ASTM D3578-19 | X Small, | |||
| Small, | |||||
| Medium, | |||||
| Large | Small, Medium, | ||||
| Large, X | |||||
| Large & XX | |||||
| Large | X-Small, Small, | ||||
| Medium, Large, X- | |||||
| Large | Similar | ||||
| (compared to | |||||
| predicate and | |||||
| reference | |||||
| devices) | |||||
| Single Use | Medical Glove | ||||
| Guidance Manual- | |||||
| Labeling | Single Use | Single Use | Single Use | Same | |
| Sterile/nonsterile | --- | Nonsterile | Non sterile | Nonsterile | Similar |
| Powder/Powder free | --- | 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 | Meets FDA's label | ||||
| and labeling | |||||
| requirements | Same | ||||
| Manufacturer(s) | --- | Hi-Care Thai | |||
| Gloves Co. | |||||
| Ltd. | JR Engineering | ||||
| & Medical | |||||
| Technologies | |||||
| (M) | |||||
| SDN BHD | THAI RUBBER | ||||
| GLOVES CO., LTD. | --- |
There are no significant differences between the products and are identical in terms of intended use, materials, design and manufacturing methods. Devices meet the ASTM standard D3578-19.
8
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 : 244 mm
Medium : 247 mm
Large : 240 mm
X-Large : 247 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 Large : 120+/-10 mm | X-Small : 77 mm
Small : 80 mm
Medium : 92 mm
Large : 101 mm
X-Large : 110 mm |
| TEST
METHOD | PURPOSE | ACCEPTANCE
CRITERIA | RESULT | | |
|--------------------------------------------------------------------------------|-----------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|---------|---------------|--------------|
| | | | | | |
| 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 | 0.115 mm | 0.125 mm |
| | | | Small | 0.115 mm | 0.128 mm |
| | | | Medium | 0.115 mm | 0.132 mm |
| | | | Large | 0.121 mm | 0.135 mm |
| | | | X Large | 0.109 mm | 0.122 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 | 26.2 MPa | 24.1 MPa |
| | | | Small | 25.0 MPa | 24.1 MPa |
| | | | Medium | 24.0 MPa | 23.4 MPa |
| | | | Large | 22.6 MPa | 24.3 MPa |
| | | | X Large | 24.2 MPa | 22.5 MPa |
| ASTM D3578-19
Standard
Specification for
Rubber
Examination Gloves | 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 | 830% | 800% |
| | | | Small | 790% | 760% |
| | | | Medium | 810% | 830% |
| | | | Large | 800% | 810% |
| | | | X Large | 800% | 780% |
9
| 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 | $\leq$ 2 mg/glove | X-Small : 0.60 mg/glove
Small : 0.80 mg/glove
Medium : 1.46 mg/glove
Large : 0.62 mg/glove X-
Large : 1.13 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 $\mu$ g/ dm² Max | Medium : 191.9 $\mu$ g/ 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 the device is
"cytotoxic" |
| 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 did not reveal
any systemic toxicity |
10
The performance test data of the non-clinical tests that support a determination of safety and equivalence is the same as mentioned above (ASTM Requirements).
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 Medical Gloves
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 devices in 510(K) submission, Latex Examination Powder Free Gloves, are as safe, as effective, and performs as well as or better than the legally marketed predicate device K202377.