(233 days)
Not Found
No
The 510(k) summary describes a standard examination glove and does not mention any AI or ML components or functionalities.
No
Explanation: The device is an examination glove, intended to prevent contamination between patient and examiner, not to provide therapy.
No
Explanation: The device is an examination glove, intended to prevent contamination between patient and examiner, not to diagnose a condition.
No
The device is a physical examination glove, not a software application. The description clearly states it is a disposable device worn on the hand and made from acrylonitrile-butadiene copolymer dispersion.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is a glove worn on the hand to prevent contamination between patient and examiner. This is a physical barrier function, not a diagnostic test performed on a sample from the body.
- Device Description: The description confirms it's a Class I patient examination glove made of nitrile. This aligns with a physical barrier device.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing a biological sample (blood, urine, tissue, etc.)
- Detecting or measuring a substance in a sample
- Providing information for diagnosis, monitoring, or screening
- Using reagents or other chemicals to perform a test
The device is a medical device, specifically a Class I examination glove, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Pro Guard Nitrile Powder free Examination Glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Product codes
LZA
Device Description
Black Nitrile Examination Gloves Powder Free are Class I patient examination gloves bearing the product code Nitrile - LZA (21 CFR 880.6250). The gloves are made from acrylonitrile-butadiene copolymer dispersion. These gloves are black in color and are powder free.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Non-clinical testing was performed to determine the performance of the Pro Guard Nitrile Powder Free Examination Glove.
Tests conducted include:
- Dimension (Length, Width, Thickness) according to ASTM D6319-19. All dimensions met the acceptance criteria and passed.
- Watertight test (1000 ml) according to ASTM D5151-19. Sample size: 200 pcs, Acceptance Number 7. All glove sizes (Extra Small, Small, Medium, Large, Extra Large) had 0 (Zero) holes and passed.
- Residual powder according to ASTM D6124-06 (Reapproved 2017). Acceptance criteria: 2 mg per glove or less. Results ranged from 1.24 mg/glove to 1.42 mg/glove for different sizes, meeting the criteria and passing.
- Physical Properties (Tensile strength and Ultimate Elongation) according to ASTM D6319-19.
- Tensile Strength: Before Ageing, all sizes were above 14 MPa min. After ageing, all sizes were 14.00 MPa or above, meeting the minimal requirement and passing.
- Ultimate Elongation: Before Ageing, all sizes were above 500% min. After ageing, all sizes were above 400% min, meeting the minimal requirement and passing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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, there is a seal with an abstract design. To the right of the seal, there is the FDA logo in blue, followed by the words "U.S. FOOD & DRUG" in a larger font and "ADMINISTRATION" in a smaller font. The logo is simple and professional, and it is easily recognizable.
August 6, 2022
Medical Glove Co., Ltd Teoh Choh Shee Managing Director 288, Moo 7, Tambon Lam Thap, Krabi 81190 Thailand
Re: K213934
Trade/Device Name: Pro Guard Nitrile Powder Free Examination Glove Regulation Number: 21 CFR 880.6250 Regulation Name: Non-powdered patient examination glove Regulatory Class: Class I, reserved Product Code: LZA Dated: June 17, 2022 Received: June 30, 2022
Dear Teoh Choh Shee:
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 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
1
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.
Bifeng Oian, M.D., 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
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known) K213934
Device Name
Pro Guard® Nitrile Powder Free Examination Glove
Indications for Use (Describe)
Pro Guard ® Nitrile Powder free Examination Glove is a disposable device intended for medical purposes 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
Image /page/3/Picture/0 description: The image shows the logo for "MG Medical Glove". The letters "MG" are large and bolded on the left side of the image. To the right of the letters is the text "Medical Glove".
510(k) SUMMARY (K213934) Nitrile Powder Free Examination Gloves
1.0 Submitter:
| Applicant: | Medical Glove Co., Ltd.
288, Moo 7, Tambon Lam Thap,
Amphur Lam Thap, Krabi 81190, Thailand |
|-------------------------|---------------------------------------------------------------------------------------------------|
| Phone Number: | +66 98 0166138 |
| Fax Number: | +66 75 626500 |
| Name of Contact Person: | Teoh Choh Shee (Mr.) |
| Preparation date: | July 19, 2022 |
2.0 Identification of the subjected device:
| Trade/Proprietary Name(s): | Pro Guard® Nitrile Powder Free Examination Glove. |
|---|---|
| Common Name: | Nitrile Powder Free Examination Gloves |
| Classification Name: | Patient Examination Gloves |
| Device Classification: | I |
| Product code | LZA |
| Regulation Number: | 21 CFR 880.6250 |
3.0 Predicate Device:
| Device Name: | Powder Free Nitrile Patient Examination Glove, Black Colored,
Non-Sterile. |
|------------------------|-------------------------------------------------------------------------------|
| 510(k): | K143131 |
| Common Name: | Patient Examination Gloves |
| Classification Name: | Patient Examination Gloves |
| Device Classification: | I |
| Product Code: | LZA |
| Regulation Number: | 21 CFR 880.6250 |
4.0 Description of the Device:
Black Nitrile Examination Gloves Powder Free are Class I patient examination gloves bearing the product code Nitrile - LZA (21 CFR 880.6250). The gloves are made from acrylonitrile-butadiene copolymer dispersion. These gloves are black in color and are powder free.
4
Image /page/4/Picture/0 description: The image shows the logo for MG Medical Glove. The letters "MG" are in large, bold, yellow font on the left side of the image. To the right of the letters, the words "MEDICAL GLOVE" are stacked on top of each other, also in yellow font.
5.0 Indication for Use:
Pro Guard® Nitrile Powder Free Examination Glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
6.0 Summary of Technological Characteristics of the Device Compared to the Predicate Device:
| Characteristics | Standards | Device performance | Comparison | |
|---|---|---|---|---|
| Predicate | Current (K213934) | |||
| 510(k) Number | - | K143131 | New 510(k) submission | Not Available |
| Manufacturer(s) | - | Kossan International Sdn. Bhd | Medical Glove Co., Ltd | ---- |
| Indication for Use | Medical Gloves Guidance Manual - Issued on January 22, 2008 | A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner | Pro Guard® Nitrile Powder free Examination Glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. | Similar |
| Design Material | ASTM D6319-19 | Nitrile | Nitrile | Same |
| Color | - | Black | Black | Same |
| Design | - | Ambidextrous, in different sizes per ASTM D6319 dimension requirement | Ambidextrous, in different sizes per ASTM D6319 dimension requirement | Same |
| Device Classification | - | Class I | Class I | Same |
| Shelf life | - | No data is available | 3 years | Different |
| Size | ASTM D6319-19 | Extra Small | ||
| Small | ||||
| Medium | ||||
| Large | ||||
| Extra Large | ||||
| XX-Large | Extra Small | |||
| Small | ||||
| Medium | ||||
| Large | ||||
| Extra Large | Different | |||
| Single Use | Medical Gloves Guidance Manual - Issued on January 22, 2008 | Single use | Single use | Same |
| Sterility | - | Non-sterile | Non-sterile | Same |
| Characteristics | Standards | Device performance | Comparison | |
| Predicate | Current (K213934) | |||
| Dimension | ASTM D6319-19 | Length | ||
| $\ge$ 230 mm minimum | Length | |||
| 230 mm min | Similar | |||
| Width | Width | |||
| X-Small 70-80 mm | Extra Small: 70 + 10 mm | |||
| Small 80-90 mm | Small: 80 + 10 mm | |||
| Medium 90-100 mm | Medium: 95 ± 10 mm | |||
| Large 101-111 mm | Large: 110± 10 mm | |||
| Extra Large: 120 ± 10 mm | ||||
| X-Large 111-121 mm | ||||
| XX-Large 121-131 mm | ||||
| Thickness | ASTM D6319-19 | Finger: 0.05 mm min | ||
| Palm: 0.05 mm min | Finger: 0.05 mm min | |||
| Palm: 0.05 mm min | Same | |||
| Physical | ||||
| Properties | ASTM D6319-19 | Before aging | Before aging | Same |
| Tensile Strength: | Tensile Strength: | |||
| 14 MPa min | 14 MPa min | |||
| Ultimate Elongation: | ||||
| 500% min | Ultimate Elongation: | |||
| 500% min | ||||
| After aging | After aging | |||
| Tensile Strength | ||||
| 14 MPa min | Tensile Strength | |||
| 14 MPa min | ||||
| Ultimate Elongation: | ||||
| 400% min | Ultimate Elongation: | |||
| 400% min | ||||
| Watertight test | ||||
| (1000 ml) | ASTM D5151-19 | Pass AQL 1.5 | Pass AQL 1.5 | Same |
| Powder Residue | ASTM D6124-06 | |||
| (Reapproved 2017) | $\le$ 2.0 mg/glove | $\le$ 2.0 mg/glove | Similar |
5
Image /page/5/Picture/0 description: The image shows the words "MG MEDICAL GLOVE" in a yellow font. The letters "MG" are larger than the other words. The words "MEDICAL GLOVE" are stacked on top of each other. The background is white.
MEDICAL GLOVE CO., LTD
288 Moo 7 T. Lam Thap, A. Lam Thap, Krabi 81190 Thailand.
Cell Phone: +66 98016 6138 . Email_inquiry@medicalglove.net
6
Image /page/6/Picture/0 description: The image shows the logo for MG Medical Glove. The letters "MG" are in large, bold, yellow font on the left side of the image. To the right of "MG" are the words "MEDICAL GLOVE" in a smaller, yellow font. The logo is simple and easy to read.
MEDICAL GLOVE CO., LTD
288 Moo 7 T. Lam Thap, A. Lam Thap, Krabi 81190 Thailand.
Cell Phone: +66 98016 6138 . Email_inquiry@medicalglove.net
| Characteristics | Standards | Device performance | ||
|---|---|---|---|---|
| Predicate | Current (K213934) | Comparison | ||
| Biocompatibility | Primary Skin | |||
| Irritation - | ||||
| ISO 10993-10 Third | ||||
| Edition 2010-08-01 | Under the conditions | |||
| of the study, not an | ||||
| irritant | Under the conditions | |||
| of the study, not an | ||||
| irritant | Same | |||
| Dermal | ||||
| Sensitization - | ||||
| ISO 10993-10 Third | ||||
| Edition 2010-08-01 | 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) | No data is available | Under the conditions of the | ||
| study, cytotoxic for undiluted, | ||||
| 1:2, 1:4 and 1:8 dilutions, but | ||||
| non-cytotoxic for 1:16 and | ||||
| 1:32 dilutions. Moreover, | ||||
| under the conditions of the | ||||
| study, non acute systemic | ||||
| toxic. | Different | |||
| Acute Systemic | ||||
| Toxicity ISO10993- | ||||
| 11:2017(E) | No data is available | Under the conditions of the | ||
| study, did not induce any | ||||
| systemic toxicity. | Different |
There are no significant differences between the two products and are identical in terms of intended use, materials, design, manufacturing methods. Both devices meet the ASTM standards.
7
Image /page/7/Picture/0 description: The image shows the logo and contact information for Medical Glove Co., LTD. The logo features the letters "MG" in a stylized font, with the words "MEDICAL GLOVE" stacked vertically to the right of the letters. The contact information includes the company's address at 288 Moo 7 T. Lam Thap, A. Lam Thap, Krabi 81190 Thailand, as well as a cell phone number of +66 98016 6138 and an email address of inquiry@medicalglove.net.
7.0 Non-clinical testing summary
Performance Data
| Test Method | Standard | Purpose of testing | Acceptance Criteria | Result | Status |
|---|---|---|---|---|---|
| ASTM D6319-19 | |||||
| Standard Specification for Nitrile | |||||
| Examination Gloves for Medical | |||||
| Application | To determine the length | ||||
| of the gloves | Min 230 mm for all sizes | Extra Small: min 240 mm | |||
| Small: min 243 mm | |||||
| Medium: min 241 mm | |||||
| Large: min 240 mm | |||||
| Extra Large: min 240 mm | Pass | ||||
| Dimension | ASTM D6319-19 | ||||
| Standard Specification for Nitrile | |||||
| Examination Gloves for Medical | |||||
| Application | To determine the width | ||||
| of the gloves | Extra Small: $70 \pm 10$ mm | ||||
| Small: $80 \pm 10$ mm | |||||
| Medium: $95 \pm 10$ mm | |||||
| Large: $110 \pm 10$ mm | |||||
| Extra Large: $120 \pm 10$ mm | Extra Small: 75 mm | ||||
| Small: 85 mm | |||||
| Medium: 95 mm | |||||
| Large: 105 mm | |||||
| Extra Large: 115 mm | Pass | ||||
| ASTM D6319-19 | |||||
| Standard Specification for Nitrile | |||||
| Examination Gloves for Medical | |||||
| Application | To determine the | ||||
| thickness of the gloves | Palm 0.05 mm min | ||||
| Finger 0.05 mm min for all sizes | Extra Small: Palm 0.09 mm, Finger: 0.12 | ||||
| mm | |||||
| Small: Palm 0.09 mm, Finger: 0.13 mm | |||||
| Medium: Palm: 0.09 mm, Finger: 0.12 | |||||
| mm | |||||
| Large: Palm 0.09 mm, Finger: 0.12 mm | |||||
| Extra Large: Palm 0.09 mm, Finger: 0.12 | |||||
| mm | Pass | ||||
| Watertight test | ASTM D5151-19 | ||||
| Standard Test Method for Detection | |||||
| of Holes in Medical | |||||
| Gloves | To determine the holes in | ||||
| the gloves | Sample size: 200 pcs | ||||
| Inspection level : GI | |||||
| AQL 1.5 | |||||
| Acceptance Number 7 | |||||
| Rejection Number 8 | The batch size for this sampling is | ||||
| 35,001-150,000. Hence, according to the | |||||
| single sampling plan GI, the sample to be | |||||
| drawn is under code L equivalent to 200 | |||||
| pcs with accept 7 and reject 8 to be | |||||
| accept under AQL 1.5. | |||||
| Extra Small: 0 (Zero) | |||||
| Small: 0 (Zero) | |||||
| Medium: 0 (Zero) | |||||
| Large:0 (Zero) | |||||
| Extra Large:0 (Zero) | Pass | ||||
| Test Method | Standard | Purpose of testing | Acceptance Criteria | Result | Status |
| Residual | |||||
| powder | ASTM D6124-06 (Reapproved 2017) | ||||
| Standard Test Method for Residual | |||||
| Powder on Medical Gloves | To determine the residual | ||||
| powder in the gloves | 2 mg per glove or less | Sample size : 5 pcs | |||
| Requirement: 2 mg per glove or less | |||||
| Result | |||||
| : | |||||
| Extra Small: 1.35 mg/glove | |||||
| Small:1.42 mg/glove | |||||
| Medium: 1.24 mg/glove | |||||
| Large: 1.34 mg/glove | |||||
| Extra Large:1.36 mg/glove | Pass | ||||
| Physical | |||||
| Properties | ASTM D6319-19 | ||||
| Standard Specification for Nitrile | |||||
| Examination Gloves for Medical | |||||
| Application | To Determine the | ||||
| physical properties- | |||||
| Tensile strength | Before Ageing | ||||
| Tensile Strength 14Mpa | |||||
| Minimal for all sizes | |||||
| After Ageing Tensile | |||||
| Strength 14Mpa | |||||
| Minimal for all sizes | Before Ageing | ||||
| Extra Small: 18.08 MPa | |||||
| Small: 18.37 MPa | |||||
| Medium: 24.56 MPa | |||||
| Large: 18.30 MPa | |||||
| Extra Large: 18.20 MPa | |||||
| After ageing: | |||||
| Extra Small: 14.01 MPa | |||||
| Small: 14.08 MPa | |||||
| Medium: 20.41 MPa | |||||
| Large: 14.00 MPa | |||||
| Extra Large: 14.00 MPa | Pass | ||||
| To Determine the | |||||
| physical properties- | |||||
| Ultimate Elongation | Before Ageing | ||||
| Ultimate Elongation | |||||
| 500% Min for all sizes | |||||
| After Ageing Ultimate | |||||
| Elongation 400% Min | |||||
| for all sizes | Before Ageing | ||||
| Extra Small: 611 % | |||||
| Small: 612% | |||||
| Medium: 645 % | |||||
| Large:620% | |||||
| Extra Large:587% | |||||
| After ageing: | |||||
| Extra Small: 412 % | |||||
| Small:408% | |||||
| Medium: 584% | |||||
| Large:403% | |||||
| Extra Large:416% | Pass |
8
Image /page/8/Picture/0 description: The image shows the logo for MG Medical Glove. The letters "MG" are in large, bold, yellow font on the left side of the image. To the right of "MG" are the words "MEDICAL GLOVE" stacked on top of each other, also in yellow font. The logo appears to be for a medical glove company.
MEDICAL GLOVE CO., LTD
288 Moo 7 T. Lam Thap, A. Lam Thap, Krabi 81190 Thailand.
Cell Phone: +66 98016 6138 . Email: inquiry@medicalglove.net
9
Image /page/9/Picture/0 description: The image shows the logo for MG Medical Glove. The letters "MG" are in large, bold, yellow font on the left side of the image. To the right of the letters "MG" is the text "MEDICAL GLOVE" in a smaller, yellow font.
MEDICAL GLOVE CO., LTD 288 Moo 7 T. Lam Thap, A. Lam Thap, Krabi 81190 Thailand.
Cell Phone: +66 98016 6138 . Email:inquiry@medicalglove.net
8.0 Clinical Testing Summary
Not applicable - Clinical data is not needed for gloves or for most devices cleared by the 510(k) process.
9.0 Conclusion:
The conclusions drawn from the non-clinical test demonstrate that the subject device Nitrile Powder Free Examination Glove is as safe, as effective, and performs as well as or better than the legally marketed predicate device K143131
---END---