(339 days)
The Single-use medical poly (vinyl chloride) examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
The proposed device is Powder Free Vinyl Patient Examination Gloves which is made of poly vinyl chloride. The proposed device is clear, non-colored. The design of proposed device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D5250. The proposed device is non-sterile.
This document is a 510(k) Pre-Market Notification for a medical device: "Single-use medical poly (vinyl chloride) examination glove." It's primarily a comparison to a predicate device to establish substantial equivalence, not a study proving device meeting acceptance criteria in the context of advanced AI/medical imaging devices. Therefore, many of the requested categories are not applicable.
Here's an analysis based on the provided text, focusing on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally based on meeting the specifications of various ASTM and ISO standards for medical examination gloves. The reported device performance indicates that the proposed device meets these criteria.
| Test Item | Acceptance Criteria (Pass Criteria) | Reported Device Performance (Verdict) |
|---|---|---|
| Dimension (mm) | ASTM D5250 | Pass |
| Overall Length | Min 230 | >230/ Pass |
| Width | XS: 76±6; S: 85±5; M: 95±5; L: 105±5; XL: 115±5 | XS: 79-81/ Pass; S: 85-87 /Pass; M: 95-97/ Pass; L: 105-107/ Pass; XL: 115-117/ Pass |
| Finger thickness | 0.05 | 0.09-0.12/ Pass |
| Palm thickness | 0.08 | 0.08-0.09/ Pass |
| Freedom from Holes | Meet the requirements of ASTM D5151 AQL 1.5 | 0/125, 1/ 125, 4/315, 5/500, 3/200 leaks / Pass (Implies AQL 1.5 met) |
| Powder Content | Meet the requirements of ASTM D6124 < 2.0mg | 0.3 – 0.42/ Pass |
| Physical Properties | ASTM D412 | Pass |
| Tensile Strength (MPa) | Meet the requirements of ASTM D412 Min 11 | 14-19/ Pass |
| Ultimate Elongation (%) | Meet the requirements of ASTM D412 Min 300% | 390 – 430/ Pass |
| Biocompatibility | ||
| Irritation | Non-irritating (ISO 10993-10) | Under the conditions of the study, not an irritant/ Pass |
| Sensitization | Non-sensitizing (ISO 10993-10) | Under conditions of the study, not a sensitizer./ Pass |
| Cytotoxicity | Non-cytotoxic (ISO 10993-5) | Under conditions of the study, did not show potential toxicity to L-929 cells./ Pass |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document provides sample sizes for the "Freedom from Holes" test (e.g., 0/125, 1/125, 4/315, 5/500, 3/200 leaks). These numbers likely refer to the number of failed units out of the total tested for specific batches or sample groups to demonstrate compliance with AQL (Acceptable Quality Level) 1.5. For other tests like Dimensions, Powder Content, Physical Properties, and Biocompatibility, specific sample numbers are not explicitly stated, but are implied to be sufficient for compliance with the stated ASTM and ISO standards.
- Data Provenance: The document does not specify the country of origin of the data. Given the applicant is Anhui Bytech Medical Supplies Co., Ltd. in China and the submission correspondent is Shanghai SUNGO Management Consulting Co., Ltd. also in China, it's highly probable the testing was conducted in China. The data is based on non-clinical performance testing, effectively a prospective quality control assessment of manufactured gloves against established standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- This section is not applicable to this type of device submission. The "ground truth" for these tests are objective measurements against established technical standards (ASTM, ISO), not expert consensus on medical interpretation.
4. Adjudication Method for the Test Set
- This section is not applicable. The tests performed are objective measurements against defined criteria in standards, not subjective assessments requiring adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices where human readers interpret results with and without AI assistance. This document describes a physical medical device (examination glove).
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI algorithm. The device is a physical glove. Performance is measured directly from the physical characteristics of the glove.
7. The Type of Ground Truth Used
- The "ground truth" for the non-clinical performance and biocompatibility tests are the specifications and acceptable limits defined within the referenced international standards (ASTM D5250, ASTM D5151, ASTM D6124, ASTM D412, ISO 10993-10, ISO 10993-5). This is an objective, standardized basis for evaluation.
8. The Sample Size for the Training Set
- This concept is not applicable here. There is no "training set" in the context of an AI/machine learning model. The device's manufacturing process is designed to produce gloves meeting specifications, not "trained" on data.
9. How the Ground Truth for the Training Set was Established
- Not applicable, as there is no training set for this device.
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May 10, 2021
Anhui Bytech Medical Supplies Co., Ltd. % Ivy Wang Technical Manager Shanghai SUNGO Management Consultanting Co., Ltd. 13th F, 1500# Century Avenue Shanghai, Shanghai 200122 China
Re: K201504
Trade/Device Name: Single-use medical poly (vinyl chloride) examination glove Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LYZ Dated: June 5, 2020 Received: June 5, 2020
Dear Ivy 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.
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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 and Part medical device reporting (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, Ph.D. Acting 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
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Indications for Use
510(k) Number (if known) K201504
Device Name
Single-use medical poly (vinyl chloride) examination glove
Indications for Use (Describe)
The Single-use medical poly (vinyl chloride) examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands 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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510(K) Summary
K201504 Date of preparation: 05 -10-2021
A. Applicant
Name: ANHUI BYTECH MEDICAL SUPPLIES CO., LTD. Address: LingBi Economic Development Zone (North), SuZhou City, Anhui Provice Name: Mr. Cheng Wang Tel: +86-0557-6602888 Fax: +86-0557-6602888
Submission Correspondent: Primary contact: Ms. Ivy Wang Shanghai SUNGO Management Consulting Co., Ltd. Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-58817802 Email: haiyu.wang@sungoglobal.com Secondary contact: Mr. Raymond Luo Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-68828050 Email: fda.sungo@@gmail.com
B. Device
Trade Name: Single-use medical poly (vinyl chloride) examination glove Common Name: Vinyl Patient Examination Gloves (Powder Free) Model(s): XS, S, M, L, XL
Regulatory Information Classification Name: Vinyl Patient Examination Gloves (Powder Free) Classification: Class I. Product code: LYZ Regulation Number: 21 CFR 880.6250 Review Panel: General Hospital
C. Predicate device
| Sponsor | HUIFU TRADING CO., LTD. |
|---|---|
| Device Name | Vinyl Examination Glove (Clear, Non-Colored) |
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| 510(k) Number | K180849 |
|---|---|
| Product Code | LYZ |
| Regulation Number | 880.6250 |
| Regulation Class | I |
D. Indications for use of the device:
The Single-use medical poly (vinyl chloride) examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
E. Device Description:
The proposed device is Powder Free Vinyl Patient Examination Gloves which is made of poly vinyl chloride. The proposed device is clear, non-colored. The design of proposed device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D5250. The proposed device is non-sterile.
F. Comparison with predicate device
Table 1 General Comparison
| ITEM | Proposed Device(K201504) | Predicate Device (K180849) | Remark |
|---|---|---|---|
| Product Code | LYZ | LYZ | SAME |
| Regulation No. | 21 CFR 880.6250 | 21 CFR 880.6250 | SAME |
| Class | I | I | SAME |
| Intended Use | The Single-use medical poly(vinyl chloride) examinationglove is a disposable deviceintended for medical purposesthat is worn on the examiner'shands to prevent contaminationbetween patient and examiner. | The Vinyl Patient ExaminationGlove(Clear, Non-Colored) is adisposable device intended formedical purposes that is worn on theexaminer's hands to preventcontamination between patient andexaminer. | SAME |
| Powdered orPowered free | Powdered free | Powdered free | SAME |
| Design Feature | ambidextrous | ambidextrous | SAME |
| Surface Feature | Smooth | Smooth | SAME |
| Device Materials | Vinyl | Vinyl | SAME |
| Color | Clear | Clear | SAME |
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| LabelingInformation | Single-use indication, powder free, device color, device name glove size and quantity, Vinyl Examination Gloves, Non-Sterile | Single-use indication, powder free, device color, device name, glove size and quantity, Vinyl Examination Gloves, Non-Sterile | SAME |
|---|---|---|---|
| ------------------------- | ------------------------------------------------------------------------------------------------------------------------------ | ------------------------------------------------------------------------------------------------------------------------------- | ------ |
Table 2 Device Dimensions Comparison
| ITEM | Proposed Device (K201504) | Predicate Device (K180849) | Remark | |||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Size | XS | S | M | L | XL | S | M | L | XL | similar |
| Length, mm | Minimum 230 | Minimum230 | Minimum235 | Minimum245 | Minimum245 | similar | ||||
| Width, mm | 78±3 | 85±3 | 95±3 | 105±3 | 115±3 | 85±5 | 95±5 | 105±5 | 115±5 | similar |
| Thickness, mm | Finger: minimum 0.05 | Finger: minimum 0.08 | Differer | |||||||
| Palm: minimum 0.08 | Palm: minimum 0.08 | Same |
Discussion: The proposed device has slight difference on the dimensions of Length, width and finger thickness to the predicate device. However, the testing results meet the specification as stated in ASTM D5250. This difference will not affect the safety and effectiveness of the proposed device.
Table 3 Performance Comparison
| ITEM | Proposed Device(K201504) | Predicate Device(K180849) | Remark |
|---|---|---|---|
| Colorant | Clear, Non-Colored | Clear, Non-Colored | Same |
| PhysicalProperties | Before Aging | Similar | |
| Tensile Strength | 11 MPa, min | ||
| Ultimate Elongation | 300 % min | ||
| After AgingTensile StrengthUltimate Elongation | 11 MPa, min300 % min | ||
| Freedom from Holes | Be free from holes when tested in accordance with ASTM D5151 AQL = 1.5 | Be free from holes when tested in accordance with ASTM D5151 AQL =1.5 | Same |
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| Powder Content | Meets Applicable Definition forPowder Free: ≤ 2 mg per glove | 0.5 mg | Similar |
|---|---|---|---|
| ---------------- | ------------------------------------------------------------------ | -------- | --------- |
Discussion: The proposed device has slight difference on the performance of physical properties and powder content to the predicate device. However, the testing results meet the specification as stated in ASTM D5250 and ASTM D6124. This difference will not affectiveness of the proposed device. The proposed device use the same AQL=1.5 as the predicate device, which is the requirement for European market and also meet the specification as stated in ASTM D5151. This will not affect the safety and effectiveness of the proposed device.
Table 4 Safety Comparison
| ITEM | Predicate Device (K180849) | Proposed Device (K201504) | Remark | |
|---|---|---|---|---|
| Biocompatibility | Irritation | Comply with ISO 10993-10 | Under the conditions of the study not an irritant | |
| Sensitization | Under conditions of the study, not a sensitizer. | |||
| Cytotoxicity | Comply with ISO 10993-5 | Under conditions of the study, did not show potential toxicity to L-929 cells. | ||
| Label and Labeling | Meet FDA's Requirements | Meet FDA's Requirements | Same |
G. Summary of non-clinical performance testing
| Test item | Test method | Pass criteria | Test results/ Verdict | |
|---|---|---|---|---|
| Dimension(mm) | Overall Length | ASTM D5250 | Min 230 | >230/ Pass |
| Width | XS: 76±6S: 85±5M: 95±5L: 105±5XL: 115±5 | XS: 79-81/ PassS: 85-87 /PassM: 95-97/ PassL: 105-107/ PassXL: 115-117/ Pass | ||
| Finger thickness | 0.05 | 0.09-0.12/ Pass | ||
| Palm thickness | 0.08 | 0.08-0.09/ Pass | ||
| Freedom from Holes | ASTM D5151 | Meet therequirements of ASTMD5151 AQL 1.5 | 0/125, 1/ 125, 4/315,5/500, 3/200 leaks /Pass | |
| Powder Content | ASTM D6124 | Meet the requirements ofASTM D6124 < 2.0mg | 0.3 – 0.42/ Pass | |
| Physicalproperties | Tensile Strength(MPa) | ASTM D412 | Meet the requirementsof ASTM D412 Min 11 | 14-19/ Pass |
| UltimateElongation (%) | Meet the requirements ofASTM D412 Min 300% | 390 – 430/ Pass | ||
| BiocompatibilityIrritation | ISO 10993-10 | Non-irritating | Under the conditions of |
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| the study, not an irritant/ Pass | ||||
|---|---|---|---|---|
| Sensitization | ISO 10993-10 | Non-sensitizing | Under conditions of the study, not a sensitizer./ Pass | |
| Cytotoxicity | ISO 10993-5 | Non-cytotoxic | Under conditions of the study, did not show potential toxicity to L-929 cells./ Pass |
Biocompatibility testing:
- Skin sensitization & Irritation -- ISO 10993-10:2010 Biological Evaluation of Medical Devices Part A 10: Tests For Irritation And Skin Sensitization.
- A Cytotoxicity -- ISO 10993-5:2009 Biological Evaluation of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity
Performance testing:
-
Residue Powder -- ASTM D6124-06 (Reaffirmation 2017), Standard Test Method for Residual Powder on Medical Gloves
- A Freedom from holes -- ASTM D5151-06 (Reapproved 2015), Standard Test Method for Detection of Holes in Medical Gloves.
-
Physical properties & Dimensions -- ASTM D5250-06 (Reapproved 2015), Standard Specification for Poly (vinyl chloride) Gloves for Medical Application.
- A ISO 2859-1:1999, "Sampling Procedures for Inspection by Attributes - Part I: Sampling Plans Indexed by Acceptable Quality Level (AQL) for Lot-by-LotInspection.
H. Summary of Clinical Performance Test
No clinical study is included in this submission.
l. Conclusion
The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission K201504, the Single-use medical poly (vinyl chloride) examination glove is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K180849.
§ 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.