(119 days)
Not Found
No
The device description and performance studies focus on material properties and standard glove testing, with no mention of AI or ML.
No.
The device, Blue Nitrile Examination Gloves, is intended to prevent contamination between patient and examiner, not to treat or diagnose a disease or condition.
No
The document describes "Blue Nitrile Examination Gloves Powder Free" which are intended for preventing contamination, not for diagnosing medical conditions.
No
The device is a physical product (examination gloves) and not software. The description details material, physical properties, and testing related to a tangible item.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the gloves are "worn on the examiner's hand to prevent contamination between patient and examiner." This is a barrier function, not a diagnostic function performed in vitro (outside the body).
- Device Description: The description focuses on the material (Nitrile), standards met (ASTM D6319-19), and physical characteristics (color, powder-free, non-sterile, ambidextrous, single use). None of these relate to analyzing samples or providing diagnostic information.
- Performance Studies: The performance studies described are bench testing for physical properties and biocompatibility testing. These are relevant to the safety and effectiveness of a barrier device, not the accuracy of a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic results.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such function.
N/A
# Intended Use / Indications for Use
Blue Nitrile Examination Gloves Powder Free 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)
LZA
# Device Description
Blue Nitrile Examination Gloves Powder Free are equivalent to the Class I patient examination gloves bearing the product code LZA (21CFR880.6250). They meet all the current specifications listed under the ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application. They are made from Nitrile (NBR)100%. These gloves are blue in color and are powder free. The product is non-sterile, ambidextrous and single use only.
Blue Nitrile Examination Gloves Powder Free 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 / Medical purpose
# 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:
- ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application: To determine the length of the gloves. Result: X-Small : 250 mm, Small : 241 mm, Medium : 240 mm, Large : 243 mm, X-Large : 240 mm.
- ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application: To determine the width of the gloves. Result: X-Small : 80 mm, Small : 82 mm, Medium : 93 mm, Large : 103 mm, X-Large : 110 mm.
- ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application: To determine the thickness of the gloves. Result: Palm (X-Small 0.101 mm, Small 0.089 mm, Medium 0.100 mm, Large 0.098 mm, X-Large 0.094 mm), Finger (X-Small 0.121 mm, Small 0.103 mm, Medium 0.116 mm, Large 0.121 mm, X-Large 0.114 mm).
- ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application: To determine the physical properties - Tensile strength. Result: Before ageing (X-Small 24.5 MPa, Small 22.7 MPa, Medium 25.3 MPa, Large 26.4 MPa, X-Large 25.5 MPa), After ageing (X-Small 23.8 MPa, Small 24.3 MPa, Medium 31.9 MPa, Large 30.3 MPa, X-Large 27.4 MPa).
- ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application: To determine the physical properties - Ultimate Elongation. Result: Before ageing (X-Small 620%, Small 580%, Medium 530%, Large 540%, X-Large 540%), After ageing (X-Small 590%, Small 560%, Medium 530%, Large 540%, X-Large 530%).
- ASTM D5151-19 Standard Test Method for Detection of Holes in Medical Gloves: To determine the holes in the gloves. Result: 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. Result: X-Small : 1.07 mg/glove, Small : 1.49 mg/glove, Medium : 0.62 mg/glove, Large : 0.56 mg/glove, X-Large : 1.60 mg/glove.
Biocompatibility Data:
- 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. Result: 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. Result: 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. Result: 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. Result: Under the conditions of study, the device extracts did not reveal any systemic toxicity.
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 D6319-19 Standard Specification for Nitrile examination Gloves for Medical Application.
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
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.
# 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.
[K202384](https://510k.innolitics.com/search/K202384)
# 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.
Not Found
# 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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 20, 2022
Thai Rubber Gloves Co., Ltd. Manoj Zacharias Consultant Liberty Management Group Ltd. 75 Executive Dr. STE 114, Aurora, Illinois 60504
Re: K213075
Trade/Device Name: Blue Nitrile Examination Gloves Powder Free Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: December 20, 2021 Received: December 20, 2021
Dear Manoj Zacharias:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
1
statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For Clarence W. Murray III, PhD Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K213075
Device Name Blue Nitrile Examination Gloves Powder Free
Indications for Use (Describe)
Blue Nitrile Examination Gloves Powder Free 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) | ☐ |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) | ☑ |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(K) SUMMARY K213075
AS REQUIRED BY: 21CFR§807.92(C)
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 | 13 September 2021 |
B. DEVICE IDENTIFICATION
| Name of the device | Blue Nitrile Examination Gloves Powder Free |
|---|---|
| Product proprietary or trade name | Goody Gloves / Wincare / TBG Gloves |
| Common or usual name | Blue Nitrile Examination Gloves Powder Free |
| Classification name | Polymer Patient Examination Glove |
| Device Classification | Class-1 |
| Product Code | LZA |
| Regulation Number | 21 CFR 880.6250 |
| Review Panel | General Hospital |
C. PREDICATE DEVICE
| Predicate Device | Hi-Care Thai Gloves Co. Ltd. |
|---|---|
| 510(k) Number | K202384 |
| Regulatory Class | Class 1 |
| Product code | LZA |
D. DESCRIPTION OF THE DEVICE:
Blue Nitrile Examination Gloves Powder Free are equivalent to the Class I patient examination gloves bearing the product code LZA (21CFR880.6250). They meet all the current specifications listed under the ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application. They are made from Nitrile (NBR)100%. These gloves are blue in color and are powder free. The product is non-sterile, ambidextrous and single use only.
Blue Nitrile Examination Gloves Powder Free with sizes X-Small, Medium, Large and X-Large are included in the submission.
4
E. INDICATION FOR USE OF THE DEVICE:
Blue Nitrile Examination Gloves Powder Free 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 | SUBJECT | |||
| 510(K) Number | --- | K202384 | K213075 | |
| Name of device | --- | Palm Care Blue Nitrile | ||
| Examination Gloves | ||||
| Powder free | Blue Nitrile | |||
| Examination Gloves | ||||
| Powder free | --- | |||
| Dimensions - Length | ASTM D6319-19 | Length Min 230 mm | Length > 230 mm | Similar |
| Size | ||||
| Average | ||||
| X-Small | ||||
| 250 | ||||
| Small | ||||
| 241 | ||||
| Medium | ||||
| 240 | ||||
| Large | ||||
| 243 | ||||
| X-Large | ||||
| 240 | ||||
| Dimensions - Width | ASTM D6319-19 | Width Min 95+/-10mm | ||
| (for medium size) | Width 95+/-10mm | |||
| (for medium size) | Similar | |||
| Size | ||||
| Average | ||||
| X-Small | ||||
| 80 | ||||
| Small | ||||
| 82 | ||||
| Medium | ||||
| 93 | ||||
| Large | ||||
| 103 | ||||
| X-Large | ||||
| 110 | ||||
| Physical Properties- | ||||
| Tensile Strength | ASTM D6319-19 | Before Ageing | ||
| Tensile Strength | ||||
| min 14 MPa | Before Ageing | |||
| Tensile Strength > 14 MPa | Similar | |||
| Size | ||||
| Actual | ||||
| value | ||||
| X-Small | ||||
| 24.5 | ||||
| Small | ||||
| 22.7 | ||||
| Medium | ||||
| 25.3 | ||||
| Large | ||||
| 26.4 | ||||
| X-Large | ||||
| 25.5 | ||||
| After Ageing | ||||
| Tensile Strength | ||||
| min 14 MPa | After Ageing | |||
| Tensile Strength > 14 MPa | Similar | |||
| Size | ||||
| Actual | ||||
| value | ||||
| X-Small | ||||
| 23.8 | ||||
| Small | ||||
| 24.3 | ||||
| Medium | ||||
| 31.9 | ||||
| Large | ||||
| 30.3 | ||||
| X-Large | ||||
| 27.4 |
5
| CHARACTERSTICS | STANDARDS | DEVICE PERFORMANCE | Comparison | |||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| PREDICATE | SUBJECT | |||||||||||||||||||||
| 510(K) Number | K202384 | K213075 | ||||||||||||||||||||
| Physical Properties- | ||||||||||||||||||||||
| Ultimate Elongation | ASTM D6319-19 | Before Ageing | ||||||||||||||||||||
| Ultimate Elongation |
500% | Before Ageing
Ultimate Elongation > 500%
Size Actual value X-Small 620 Small 580 Medium 530 Large 540 X-Large 540 | | | | | | | | | | | | | Similar | | | | | | |
| | | After Ageing
Ultimate Elongation
400% | After Ageing
Ultimate Elongation > 400%
Size Actual value X-Small 590 Small 560 Medium 530 Large 540 X-Large 530 | | | | | | | | | | | | | Similar | | | | | | |
| Thickness | ASTM D6319-19 | Palm min 0.05 mm
Finger min 0.05 mm | Palm > 0.05 mm Finger > 0.05 mm
Size Palm
(Actual
value) Finger
(Actual
value) X-Small 0.101 0.121 Small 0.089 0.103 Medium 0.100 0.116 Large 0.098 0.121 X-Large 0.094 0.114 | | | | | | | | | | | | | | | | | | | Similar |
| Powder Residue | ASTM D6319-19 |