(297 days)
Powder Free Vinyl Patient Examination Gloved) is a non-sterile disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Powder Free Viny| Patient Examination Gloves, Clear (non-colored) are disposable devices which made of PVC material , intended for medical purpose that worn on examiner's hand or linger to prevent contamination between patient and examiner and they meets all of the requirements of ASTM standard D 5250-06 (Reapproved 2011).
Here is an analysis of the acceptance criteria and study information for the device, based on the provided text:
Acceptance Criteria and Device Performance Study
The device in question is the "Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)". Its performance is demonstrated through testing against established ASTM standards and FDA regulations for examination gloves.
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristics | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Dimension | ASTM standard D 5250-06 (Reapproved 2011) | Meets |
| Physical Properties | ASTM standard D 5250-06 (Reapproved 2011) | Meets |
| Freedom from Pinholes | 21 CFR 800.20 | Meets (specifically, Meets ASTM D5151-06 (Reapproved 2011) Holes at Inspection Level I AQL2.5) |
| Powder Residual | ASTM standard D 5250-06 (Reapproved 2011) and D6124-06 (Reapproved 2011) | Meets (<2mg/glove) |
| Biocompatibility | Primary Skin Irritation in rabbits (ISO 10993-10) | Passes (The test article was non-irritant.) |
| Dermal sensitization in the guinea pig (ISO 10993-10) | Passes (The test article was non-sensitizer.) | |
| Dimensions - Length | ASTM D5250-06 (Reapproved 2011) ≥230mm min | 230mm min for all sizes |
| Dimensions - Width | ASTM D5250-06 (Reapproved 2011) Small 80-90 mmMedium 90-100mmLarge 100-110mmXlarge 110-120 mm | Small 80-85 mmMedium 95-100mmLarge 102-108mmX large 113-118 mm |
| Dimensions - Thickness | ASTM D5250-06 (Reapproved 2011) Finger 0.05mm min.Palm 0.08mm min. | Thickness (mm) min.Finger 0.09-0.12Palm 0.09-0.12 |
| Physical Properties (Detailed) | ASTM D 5250-06 (Reapproved 2011) Before aging/after aging: Elongation ≥300%Tensile Strength ≥ 14MPa | Before aging/after aging: Elongation: 390-420%Tensile Strength: 15-20 MPa |
| Materials used | Polymer or other type of material (e.g., PVC) | PVC |
| Dusting or Donning | Lubricant composition, biocompatibility data for lubricant (if used) | PU (for surface coating agent) |
| Single Patient Use | Single Patient Use | Single Patient Use |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes for each test mentioned (e.g., how many gloves were tested for pinholes, dimensions, or physical properties). However, the testing refers to compliance with ASTM standards and 21 CFR 800.20. These standards typically define the appropriate sampling plans and statistical methods for demonstrating compliance.
- Data Provenance: The studies were conducted by Bytech Dongtai Co.,Ltd. in China. The results are reported as part of their 510(k) submission to the FDA. The testing conducted to meet ASTM and ISO standards would be considered prospective for the purpose of demonstrating device performance and substantial equivalence.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the device is a simple medical examination glove. The "ground truth" for its performance is established by objective, quantifiable physical and chemical tests against recognized national and international standards (ASTM, ISO, and 21 CFR). Expert consensus is not typically involved in establishing the ground truth for such device characteristics.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods like "2+1" or "3+1" are relevant for subjective assessments, often in clinical imaging studies where multiple readers interpret results. For physical and chemical properties of a medical glove, performance is measured objectively against predefined thresholds in standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. These studies are typically performed for diagnostic devices or AI-driven systems where human interpretation is a critical component, and the impact of the AI on human reader performance is being evaluated. This device is a passive barrier (examination glove), and its effectiveness is determined by its physical and biological properties, not by aiding human readers in diagnosis.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone performance evaluation was implicitly done. The tests conducted (Dimension, Physical Properties, Freedom from Pinholes, Powder Residual, Biocompatibility) are all evaluations of the device itself, independent of any human interaction beyond the execution of the test protocols. The device's performance is measured directly by mechanical, chemical, and biological tests, not by an algorithm or human-in-the-loop scenario.
7. The Type of Ground Truth Used
The ground truth used for these tests is based on objective, quantitative measurements against established engineering and biological standards. Specifically:
- ASTM D 5250-06 (Reapproved 2011) for dimensions and physical properties.
- 21 CFR 800.20 and ASTM D 5151-06 (Reapproved 2011) for freedom from pinholes.
- ASTM D 6124-06 (Reapproved 2011) for powder residual.
- ISO 10993-10 for biocompatibility (primary skin irritation and dermal sensitization).
These standards define the acceptable range or threshold for each characteristic, which serves as the "ground truth" for determining compliance.
8. The Sample Size for the Training Set
This information is not applicable. The device is not an AI/ML algorithm that requires a "training set". Its performance is based on manufacturing processes and material properties, which are then verified through direct testing against standards.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no "training set" for this type of medical device.
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Section C 510(k) Summary (21 CFR 807.92)
510(K) Summary
"This summary of 510(k) safety and cffectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92."
"The assigned 510(k) number is: K130101 11
Premarket Notification [5]0(k)] Summary
NOV 08 2013
| Submitter's name : | Bytech Dongtai Co.,Ltd. |
|---|---|
| Submitter's address : | Xing Yuan Industrial Park, Tang Yang Town, Dong Tai City, JiangSu, 224200 China |
| Phone number : | 0086-515-85655500 |
| Fax number : | 0086-515-85655500 |
| Name of contact person: | Mr. Wang Cheng |
| Date the summary was prepared: | 2013-09-29 |
| Device Name: | Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) |
| Proprietary/Trade name: | "Bytech" |
| Common Name: | Exam gloves |
| Classification Name: | Patient examination glove |
| Device Classification: | I |
| Regulation Number: | 21 CFR 880.6250 |
| Panel: | General Hospital (80) |
| Product Code: | LYZ |
Class I* Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) that meets all of the requirements of ASTM D 5250-06 (Reapproved 2011).
Predicate device: Powder-Free Vinyl Patient Examination Glove (Non-colored) Zhang Jia Gang Fengyuan Plastic Product Co., Ltd. K091663.
Device Description: Powder Free Viny| Patient Examination Gloves, Clear (non-colored) are disposable devices which made of PVC material , intended for medical purpose that worn on examiner's hand or linger to prevent contamination between patient and examiner and they meets all of the requirements of ASTM standard D 5250-06 (Reapproved 2011).
' Section C (rev.01)
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Device Intended Use (Indication for use): Powder Free Viny) Patient Examination Gloves, Clear (non-colored) 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 summary of the technological characteristics of new device compared to the predicate device.
The Powder Free Vinyl Patient Examination Gloves, Clear (non-colored), non sterile are summarized with the following technological characteristics compared to ASTM or equivalent standard.
| Characteristics | Standard | Device performance |
|---|---|---|
| Dimension | ASTM standard D5250-06(Reapproved 2011). | Meets |
| Physical Properties | ASTM standard D5250-06(Reapproved 2011). | Meets |
| Freedom frompinholes | 21 CFR 800.20 | Meets |
| Powder Residual | ASTM standard D 5250-06(Reapproved 2011).and D6124-06(Reapproved 2011). | Meets<2mg/glove |
| Biocompatability | Primary Skin Irritation in rabbitsISO 10993-10Dermal sensitization in the guinea pigISO 10993-10 | PassesThe test article was nonirritant.PassesThe test article was nonsensitizer. |
A brief discussion of the nonclinical submitted, reference, or relied on in the premarket notification submission for a determination of substantial equivalence .
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored), meet requirements per ASTM D5250-06 (Reapproved 2011), per ASTM D6124-06(Reapproved 2011), per 21 CFR 800.20 and ISO 10993-10: 2002/Amd. 1:2006.
The performance test data of the nonclinical tests that support a determination of substantial equivalent is the same as mentioned immediately above.
| Features &Description | Predicate Device | MedicalGuidanceManual(1661) | Glove Subject Device | Result ofComparison |
|---|---|---|---|---|
| Company | Zhang JiaFengyuanProduct Co.Ltd. | GangPlastic | Jiangsu Toptouch GloveCo., Ltd. | -- |
| 510(K) Number | K091663 | -- | ||
| Product name | Powder Free VinylPatient ExaminationGloves, Clear(Non-colored) | Powdered Free VinylPatient ExaminationGloves, Clear(non-colored) | same | |
| Product Code | LYZ | LYZ | LYZ | same |
| Size | Small/ Medium/Large/X large | Small/ Medium/Large/X large | same | |
| Intend for use | Powder free VinylPatient ExaminationGloves,Clear(Non-colored)is adisposable device | Powder FreeExamination Gloves:A powder-free patientexamination glove is adisposable device | Powder free VinylPatient ExaminationGloves, Clear(Non-colored) is adisposable device | Substantiallyequivalent |
| intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. | intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. | intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. | ||
| Device Description and Specifications | Meets ASTM D5250-06(Reapproved 2011) | If vinyl:Do the vinyl examination gloves meet all the current specifications listed under ASTM Specification D5250 or an equivalent consensus standard? | Meets ASTM D5250-06(Reapproved 2011) | Substantially equivalent |
| Dimensions--Length | Meets ASTM D5250 -06(Reapproved 2011)≥230mm min | ASTM D5250 | 230mm min for all sizes | Substantially equivalent |
| Dimensions-- Width | Meets ASTM D5250-06(Reapproved 2011) | ASTM D5250 | Substantially equivalent | |
| Small 80-90 mmMedium 90-100mmLarge 100-110mmXlarge 110-120 mm | Small 80-85 mmMedium 95-100mmLarge 102-108mmX large 113-118 mm | |||
| Dimensions--Thickness | Meets ASTM D5250-06(Reapproved 2011)Finger 0.05mm min.Palm 0.08mm min. | Thickness (mm) min.Finger 0.09-0.12Palm 0.09-0.12 | Substantially equivalent | |
| Physical Properties | Meets ASTM D 5250-06(Reapproved 2011)Before aging/after agingElongation ≥300%Tensile Strength≥ 14MPa | ASTM D5250 | Before aging/after agingElongation :390-420%Tensile Strength:15-20 MPa | Substantially equivalent |
| Freedom from Pinholes | Meets• 21 CFR 800.20• ASTM D5250-06 (Reapproved 2011)• ASTM D 5151-06 (Reapproved 2011) | 21 CFR 800.20ASTM D5250ASTM D 5151 | Meets ASTM D5151-06(Reapproved 2011)Holes at Inspection Level IAQL2.5 | Substantially equivalent |
| Residual Powder | Meets ASTM D 6124-06(Reapproved 2011)below 2mg of residual powder | ASTM D 6124 | Meets ASTM D 6124-06(Reapproved 2011)Results generated values below 2mg of residual powder | Substantially equivalent |
| Materials used to fabricate the devices | PVC | If the glove is made of a polymer or other type of material. identify the material. | PVC | Substantially equivalent |
| Dusting or Donning | PU | If a donning lubricant is used state the | PU | Substantially equivalent |
| Powder: | compositionand includebiocompatibility datafor the lubricant in anidentified attachment;also state the name,manufacturer, andaddress below | |||
| Dusting orDonningPowder: name | PU | LubricantGeneric Name/LubricantBrand Name | Surface Coating Agent | Substantiallyequivalent |
| Compareperformancedata supportingsubstantialequivalence | MeetsASTM D5151-06(Reapproved 2011)ASTM D5250-06(Reapproved 2011)ASTM D6124-06(Reapproved 2011) | At this time FDArecognizes thefollowing standards:Patient ExaminationGloves(PVC)ASTMD5151(Detection ofHoles in MedicalGloves)ASTMD6124(ResidualPowder on MedicalGloves)ASTMD5250(Poly(vinylchloride) Gloves) | MeetsASTM D5151-06(Reapproved 2011)ASTM D5250-06(Reapproved 2011)ASTM D6124-06(Reapproved 2011) | Substantiallyequivalent |
| Single PatientUse | Single Patient Use | Single Patient Use | Single Patient Use | Substantiallyequivalent |
| Biocompatibility | SKIN IRRITATIONDERMAL andSENSITIZATIONSTUDIES Meets ISO10993-10:2002/Amd.1:2006 | SKIN IRRITATIONDERMAL andSENSITIZATIONSTUDIESISO 10993-10 | The test article was nonirritant and nonsensitizer.SKIN IRRITATIONDERMAL andSENSITIZATIONSTUDIES Meets ISO10993-10:2002/Amd.1:2006 | Substantiallyequivalent |
| Labeling for thelegally marketeddevice to whichsubstantialequivalence isclaimed | -Powder Free-Patient ExaminationGlove-Single Use Only- Manufactured For:- Lot | Chapter 4 | -Powder Free-Patient ExaminationGlove-Single Use Only- Manufactured For:- Lot | Substantiallyequivalent |
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A brief discussion of the clinical submitted, reference, or relied on in the premarket notification submission for a determination of substantial equivalence .
Clinical data is not needed for gloves or for most devices cleared by the 510(k) process.
The conclusions
It can be concluded that the Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) mcct the ASTM standard or cquivalent standard and FDA requirements for waterleak test on pinhole AQL., meet labeling claims.
It can be concluded that the Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) is as safe, as effective, and performs as well as the predicate device, Powder-Free Viny] Patient Examination Glove (Non-colored) Zhang Jia Gang Fengyuan Plastic Product Co., Ltd. K091663.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - W()66-G609 Silver Spring, MD 20993-0002
November 8, 2013
Bytech Dongtai Company, Limited Mr. Wang Cheng Quality Department Manager Xing Yuan Industrial Park. Tang Yang Town Dong Tai City, JiangSue CHINA 224200
Re: K130101
Trade/Device Name: Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: 1 Product Code: LYZ Dated: September 29, 2013 Received: October 2, 2013
Dear Mr. Cheng:
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. 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 vour device is classified (see above) into cither 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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Page 2 - Mr. Cheng
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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803). please go to
http://www.lda.gov/MedicalDevices/Safetv/ReportalProblem/default.hum for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Image /page/5/Picture/7 description: The image shows a signature and some text. The text includes "Sincerely yours," followed by the name "Tejashri Purohit-Sheth, M.D." and the title "Clinical Deputy Director." The acronym "DAGRID" is also present. Finally, the word "FOR" is at the bottom right.
Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
510(k) Number (if known) K130101
Device Name
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
Indications for Use (Describe)
Powder Free Vinyl Patient Examination Gloved) is a non-sterile disposable device intended for medical purpose that is worn on the examiner's hand or finger 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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
. . . . . . . . . . . . . . . FOR EDA USE ONLY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Image /page/6/Picture/13 description: The image shows the name "Elizabeth F. Claverie" in bold, black font. Below the name, the date "2013.11.07" and the time "21:50:02" are printed in a similar font. There is a logo to the right of the name and date, but it is difficult to read.
§ 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.