(167 days)
Not Found
No
The device description and performance studies focus on the physical properties and safety of examination gloves, with no mention of AI or ML.
No
The device is a disposable medical glove intended to prevent contamination, not to treat or diagnose a disease or condition.
No
The device, "Disposable Medical Rubber Examination Gloves," is intended to prevent contamination between the patient and examiner. It does not perform any diagnostic function such as detecting, monitoring, or predicting a disease or condition. Its purpose is primarily for barrier protection.
No
The device is a physical product (gloves) made of natural rubber latex, not software. The description focuses on material properties and physical performance tests.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside the body (in vitro).
- Device Description and Intended Use: The description clearly states the device is a "Disposable Medical Rubber Examination Glove" intended to be "worn on the examiner's hand to prevent contamination between patient and examiner." This is a barrier device used for protection and hygiene, not for performing diagnostic tests on bodily samples.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples, detect substances, or provide any diagnostic information about a patient's condition.
The device described is a standard medical glove used for examination purposes.
N/A
Intended Use / Indications for Use
Disposable Medical Rubber Examination Gloves are disposable device 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
The Disposable Medical Rubber Examination Gloves are manufactured to meet the all 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 is added) and are powder free.
The proposed device(s) are sold non-sterile and are intended to be single-use, disposable devices.
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's
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 tests were conducted to demonstrate that the proposed device complies with the following standards:
ISO 10993-10: 2021 Biological Evaluation Of Medical Devices - Part 10: Tests For Skin Sensitization.
ISO 10993-23: 2021 Biological evaluation of medical devices - Part 23: Tests for irritation
ISO 10993-11 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
ASTM D3578-19 Standard Specification for Rubber Examination Gloves
Acute Systemic Toxicity Test: The test article has no potential acute system toxicity on ICR mice in the extraction method.
Skin Irritation Test: Under the experimental conditions, the test article has no skin irritation on rabbits.
Skin Sensitization Test: Under the experimental conditions, the test article has no potential skin sensitization on guinea pigs in the method.
Physical Dimensions Test: The subject device comply with the dimension requirements prescribed in ASTM D3578-19.
Physical Property Characteristics Test: Before and after accelerated aging, the subject device conform to the physical requirements specified in ASTM D3578-19 Table 3.
Freedom From Holes Test: No water leakage is inspected. The subject device conform to the requirements specified in ASTM D5151.
Powdered Glove Test: Residual Powder less than 2 mg per glove. The subject device conform to the requirements specified in ASTM D6124.
Extractable Protein Test: The results showed that the average Extractable Protein of test samples was met the acceptance criteria in ASTM D5712.
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.
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). 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.
October 26, 2022
Hebei Titans Hongsen Medical Technology Co., Ltd. % Ray Wang General Manager Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District Beijing, 102401 China
Re: K221374
Trade/Device Name: Disposable Medical Rubber Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I. reserved Product Code: LYY Dated: September 27, 2022 Received: September 27, 2022
Dear Ray Wang:
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,
Bifeng Qian, 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
Indications for Use
510(k) Number (if known) K221374
Device Name
Disposable Medical Rubber Examination Gloves
Indications for Use (Describe)
Disposable Medical Rubber Examination Gloves are disposable device 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)
X 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 K221374
-
- Date of Preparation: 10/25/2022
-
- Submitter
Hebei Titans Hongsen Medical Technology Co., Ltd.
Eastern Industrial Zone, Nangong City, Xingtai City, 051800, Hebei, China
Contact Person: Chai Wu Position: Quality Director Tel: +86-17769045117 Email: hszj@titans-cn.com
-
- Submission Correspondent
Beijing Believe-Med Technology Service Co., Ltd.
Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District, Beijing, China,102401 Contact Person: Ray Wang Position: General Manager Tel: +86-18910677558 Fax: +86-10-56335780 Email: information(@believe-med.com
-
- Subject Device Identification
Trade Name: Disposable Medical Rubber Examination Gloves
- Subject Device Identification
Common Name: Latex Patient Examination Glove
Regulatory Information: Classification: I Product Code: LYY Regulation Number: 21 CFR 880.6250 Review Panel: General Hospital
4
- న. Predicate Device Identification
K210253
BEST GLOVE -LATEX POWDER FREE EXAMINATION GLOVE
BESTSAFE GLOVE CO., LTD
Regulatory Information:
Classification: I
Product Code: LYY
Regulation Number: 21 CFR 880.6250
Review Panel: General Hospital
Common Name: Latex Patient Examination Glove
- Device Description 6.
The Disposable Medical Rubber Examination Gloves are manufactured to meet the all 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 is added) and are powder free.
The proposed device(s) are sold non-sterile and are intended to be single-use, disposable devices.
| Characteristics | Subject Device | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Single use | Single use | ||||||||||||
| Sterile/Non Sterile | Non Sterile | ||||||||||||
| Dimension | Length (mm): 230 min. | ||||||||||||
| Width (mm) | |||||||||||||
| Size Width XS 75 ± 5 S 85 ± 5 M 95 ± 5 L 105 ± 5 XL 115 ± 5 | |||||||||||||
| Thickness (mm) For all sizes: 0.08 min. | |||||||||||||
| Physical Properties | Type I | ||||||||||||
| Before Aging After Accelerated Aging Tensile Strength 18MPa, min 14 MPa, min Ultimate Elongation 650 % min 500 % min | |||||||||||||
| Freedom from holes | No water leakage is inspected. AQL 2.5 | ||||||||||||
| Powder Free Residue | Size Residual powder content (mg/glove) XS 0.28 S 0.25 M 0.31 L 0.25 XL 0.35 |
5
| Protein Content | Meet the requirements of ASTM D5712, Less than 200 $ \mu $ g/dm2 |
|---|---|
| Biocompatibility | Biocompatible |
7. Indication For Use Statement
Disposable Medical Rubber Examination Gloves are disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
-
- Technological Characteristic Comparison Summary
The subject device has same indication for use, design (single use, non-sterile), powdered free and material with the predicate device.
- Technological Characteristic Comparison Summary
The subject is different with the predicate device in dimensions, physical properties, powder free residue and protein content. But both subject device and predicate device meet the requirements of ASTM D3578-19, Standard Specification for Rubber Examination Gloves, so we conducted the testing as this standard, the test results show that the subject device meet the requirements of this standard, so these different in dimensions, physical properties, powder free residue and protein content would not raise new safety concerns.
| ITEM | References/Stand
ard | Proposed Device | Predicate Device K210253 | Remark |
|-----------------------------------------------|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Intended Use | / | Disposable Medical Rubber Examination
Gloves are disposable device intended for
medical purpose that is worn on the examiner's
hand to prevent contamination between patient
and examiner. | A powder-free 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. | SAME |
| Material | / | Natural Rubber Latex | Natural Rubber Latex | SAME |
| Color | / | Natural White | Natural Color | SAME |
| OTC use | / | Yes | Yes | SAME |
| Single Use | / | Yes | Yes | SAME |
| Sterile | / | Non-sterile | Non-sterile | SAME |
| Dimension
(Length,
Width,Thickn
ess) | ASTM D3578
S-2 AQL 4.0 | Length (mm) min | Length (mm) min | Similar |
| | | Size | Size
Actual value | |
| | | XS | Small
240 | |
| | | S | Medium
240 | |
| | | M | Large
240 | |
| | | L | Extra Large
241 | |
| | | XL | / | |
| | | Width (mm) | Width (mm) | Similar |
| | | Size
Width | Size
Actual value | |
| | | XS
75 ± 5 | Small
85 ± 10 | |
| | | S
85 ± 5 | Medium
93 ± 10 | |
| | | M
95 ± 5 | Large
105 ± 10 | |
| | | L
105 ± 5 | Extra Large
115 ± 10 | |
| | | XL
115 ± 5 | / | |
| | | Thickness (mm) For all sizes min
Finger
0.08 | Thickness (mm) min | Similar |
| | | | Size
Palm
Actual value
Finger
Actual value | |
6
| Palm | 0.08 | Small | 0.09 | 0.12 | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| / | Medium | 0.09 | 0.12 | |||||||||
| / | Large | 0.10 | 0.13 | |||||||||
| / | / | Extra | ||||||||||
| Large | 0.09 | 0.12 | ||||||||||
| Physical | ||||||||||||
| Properties | ASTM D412 | |||||||||||
| S-2 AQL 4.0 | Type I | Type I | Similar | |||||||||
| Before | ||||||||||||
| Aging | After | |||||||||||
| Accelerated | ||||||||||||
| Aging | Before Aging | After Accelerated | ||||||||||
| Aging | ||||||||||||
| Tensile | ||||||||||||
| Strength | $18\text{MPa, min}$ | $14\text{ MPa, min}$ | Tensile | |||||||||
| Strength | Size | Actual | ||||||||||
| value | Size | Actual | ||||||||||
| value | ||||||||||||
| Small | 18.04 | Small | 15.02 | |||||||||
| Medium | 19.13 | Medium | 18.12 | |||||||||
| Large | 18.26 | Large | 16.01 | |||||||||
| Extra | ||||||||||||
| Large | 18.64 | Extra | ||||||||||
| Large | 15.06 | |||||||||||
| Ultimate | ||||||||||||
| Elongation | $650 % \text{ min}$ | $500 % \text{ min}$ | Ultimate | |||||||||
| Elongation | Size | Actual | ||||||||||
| value | Size | Actual | ||||||||||
| value | ||||||||||||
| Small | 651 | Small | 501 | |||||||||
| Medium | 654 | Medium | 601 | |||||||||
| Large | 650 | Large | 501 | |||||||||
| Extra | ||||||||||||
| Large | 650 | Extra | ||||||||||
| Large | 502 | |||||||||||
| Freedom from | ||||||||||||
| holes | ASTM D5151 | No water leakage is inspected. | ||||||||||
| I AQL 2.5 | Pass AQL 2.5 | SAME | ||||||||||
| Powder Free | ||||||||||||
| Residue | ASTM D6124 | |||||||||||
| N=5 | ||||||||||||
| Less than 2.0 mg/glove | Size | Residual powder | ||||||||||
| content | ||||||||||||
| (mg/glove) | Size | Residual powder | ||||||||||
| content | ||||||||||||
| (mg/glove) | Similar | |||||||||||
| XS | 0.28 | Small | 0.62 | |||||||||
| S | 0.25 | Medium | 0.46 | |||||||||
| M | 0.31 | Large | 0.61 | |||||||||
| L | 0.25 | Extra Large | 0.61 | |||||||||
| XL | 0.35 | / | / | |||||||||
| Protein | ||||||||||||
| Content | ASTM D5712 | |||||||||||
| N=3 | ||||||||||||
| Less than 200 µg/dm² | Less than 200 µg/dm² | Protein Content (µg/dm²) | Similar | |||||||||
| Size | Actual value | |||||||||||
| Small | 124.36 | |||||||||||
| Medium | 140.78 | |||||||||||
| Large | 134.26 | |||||||||||
| Extra Large | 159.46 | |||||||||||
| Cytotoxicity | ISO 10993-11 | |||||||||||
| The test article showed | ||||||||||||
| "negative" systemic | ||||||||||||
| toxicity | Under the conditions of the study, the test | |||||||||||
| article showed "negative" systemic toxicity. | Non-cytotoxic | SAME | ||||||||||
| Irritation | ISO 10993-23 | |||||||||||
| The response of the test | ||||||||||||
| article has no skin | ||||||||||||
| irritation | Under the experimental conditions, the test | |||||||||||
| article has no skin irritation on rabbits. | Non-irritating | SAME | ||||||||||
| Sensitization | ISO 10993-10 | |||||||||||
| The test article showed | ||||||||||||
| no evidence of causing | ||||||||||||
| delayed dermal contact | ||||||||||||
| sensitization. | The test article showed no evidence of causing | |||||||||||
| delayed dermal contact sensitization in the | ||||||||||||
| guinea pig. | Non-sensitizing | SAME |
9. Summary of Non-Clinical Testing
Bench tests were conducted to demonstrate that the proposed device complies with the following standards:
ISO 10993-10: 2021 Biological Evaluation Of Medical Devices - Part 10: Tests For Skin Sensitization.
ISO 10993-23: 2021 Biological evaluation of medical devices - Part 23: Tests for irritation ISO 10993-11 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity ASTM D3578-19 Standard Specification for Rubber Examination Gloves
7
| Test Item | Test Method | Test Purpose/Description | Acceptance Criteria | Results |
|---|---|---|---|---|
| Acute | ||||
| Systemic | ||||
| Toxicity | ||||
| Test | Extraction Method | The test was designed to | ||
| evaluate the potential acute | ||||
| system toxicity caused by | ||||
| test article contact with the | ||||
| ICR | ||||
| mice | ||||
| and | ||||
| extrapolating the results to | ||||
| humans. | ISO 10993-11 | |||
| Biological evaluation of | ||||
| medical devices - Part | ||||
| 11: Tests for systemic | ||||
| toxicity. | The test article | |||
| has no potential | ||||
| acute system | ||||
| toxicity on ICR | ||||
| mice in the | ||||
| extraction | ||||
| method. | ||||
| Skin | ||||
| Irritation | ||||
| Test | Extraction Method | To evaluate the potential | ||
| skin irritation caused by | ||||
| test article contact with the | ||||
| skin surface of rabbits and | ||||
| extrapolating the results to | ||||
| humans, but it does not | ||||
| establish the actual risk of | ||||
| irritation. | ISO 10993-23: 2021 | |||
| Biological evaluation of | ||||
| medical devices - Part | ||||
| 23: Tests for irritation. | Under the | |||
| experimental | ||||
| conditions, the | ||||
| test article has | ||||
| no skin | ||||
| irritation on | ||||
| rabbits. | ||||
| Skin | ||||
| Sensitization | ||||
| Test | Guinea | |||
| Pig | ||||
| Maximization | The test was designed to | |||
| evaluate the potential of a | ||||
| test article to cause skin | ||||
| sensitization. The test is | ||||
| used as a procedure for | ||||
| screening of contact | ||||
| allergens in guinea pigs | ||||
| and extrapolating the | ||||
| results to humans, but it | ||||
| does not establish the | ||||
| actual risk of sensitization. | ISO 10993-10: 2021 | |||
| Biological Evaluation | ||||
| Of Medical Devices - | ||||
| Part 10: Tests For Skin | ||||
| Sensitization. | Under the | |||
| experimental | ||||
| conditions, the | ||||
| test article has | ||||
| no potential | ||||
| skin | ||||
| sensitization on | ||||
| guinea pigs in | ||||
| the method. | ||||
| Physical | ||||
| Dimensions | ||||
| Test | Use steel ruler and | |||
| the apparatus for | ||||
| measurement of | ||||
| thickness (0-10mm) | ||||
| to measure gloves | ||||
| Physical dimensions. | The gloves shall comply | |||
| with the dimension | ||||
| requirements prescribed in | ||||
| ASTM D3578-19 Table 2. | Inspection Level: S-2 | |||
| AQL: 4.0 | The subject | |||
| device comply | ||||
| with the | ||||
| dimension | ||||
| requirements | ||||
| prescribed in | ||||
| ASTM D3578- |
-
|
| Physical
Property
Characteristics Test | Dumbbell and
Straight Section
Specimens. | Before and
after accelerated aging, the
gloves shall conform to the
physical requirements
specified in ASTM
D3578-19 Table 3. | Inspection Level:
AQL: | Before and after
accelerated
aging, the
subject device
conform to the
physical
requirements
specified in
ASTM D3578-
19 Table 3. |
| Freedom
From Holes
Test | Refer to the ASTM
D 5151-06, Standard
Test Method for
Detection of Holes in
Medical Gloves. | This test method is to the
detection of holes that
allow water leakage under
the conditions of the test. | Inspection Level: I
AQL: 2.5 | No water
leakage is
inspected.
The subject
device conform
to the
requirements
specified in
ASTM D5151. |
| Powdered
Glove Test | Refer to the ASTM
D 6124-06, R2017,
Standard Test
Method for Residual
Powder on Medical
Gloves. | These test are the
determination of average
powder or filter-retained
mass found on a sample of
medical gloves as
described in the
introduction. | Inspection Level: N=5
Residual Powder less
than 2 mg per glove. | Residual
Powder less
than 2 mg per
glove.
The subject
device conform
to the
requirements
specified in
ASTM D6124. |
| Extractable
Protein Test | Refer to the ASTM
D5712 Standard Test
Method for Analysis
of Aqueous
Extractable Protein
in Latex, Natural
Rubber, and
Elastomeric Products
Using the Modified
Lowry Method. | The test was designed to
test the laechable protein
of the test glove. | Inspection Level: N=3
Less than 200 µg/dm². | The results
showed that the
average
Extractable
Protein of test
samples was
met the
acceptance
criteria in
ASTM D5712. |
8
9
-
- Summary of Clinical Testing Not applicable
-
- Conclusions
Based on the nonclinical tests performed, the subject device is as safe, as effective, and performs as well as the legally marketed predicate device, BEST GLOVE -LATEX POWDER FREE EXAMINATION GLOVE, cleared under K210253.