(351 days)
Powder Free Vinyl Patient Examination Gloved) is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) that meets all of the requirements of ASTM standard D 5250-06(Reaffirmation 2011).
The provided document is a 510(k) summary for "Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)". This type of medical device submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance and material characteristics, rather than clinical studies with human subjects or AI-driven performance metrics. Therefore, many of your requested points regarding acceptance criteria, study design, and AI performance are not applicable to this document.
However, I can extract the relevant information regarding the acceptance criteria and the methods used to prove the device meets these criteria.
Acceptance Criteria and Device Performance Study for Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
This summary is based on the provided 510(k) submission, K130751. The device in question is a Class I medical device (patient examination glove), and its clearance relied on demonstrating substantial equivalence to a predicate device by meeting established ASTM standards and other regulatory requirements. Clinical studies and AI performance metrics are not applicable to this type of device and submission.
1. Table of Acceptance Criteria and Reported Device Performance
The device meets the requirements of ASTM standard D 5250-06 (Reaffirmation 2011), ASTM D5151-06 (Reapproved 2011), ASTM D6124-06 (Reapproved 2011), 21 CFR 800.20, and ISO 10993-10: 2002/Amd. 1:2006(E).
| Feature | Acceptance Criteria (ASTM D5250-06 (Reapproved 2011) & other standards) | Reported Device Performance (Subject Device) |
|---|---|---|
| Material | PVC | PVC |
| Donning Powder | PU / Surface Coating Agent | PU / Surface Coating Agent (Results generated values below 2mg residual powder) |
| Length | ≥230mm min. for all sizes (ASTM D5250) | 230mm min for all sizes |
| Width | Small 80-90mm, Medium 90-100mm, Large 100-110mm, X large 110-120mm | Small 80-85mm, Medium 95-97mm, Large 102-108mm, X large 114-118mm |
| Thickness | Finger 0.05mm min., Palm 0.08mm min. (ASTM D5250) | Finger 0.05mm min., Palm 0.08mm min. |
| Elongation (Physical) | Before aging/after aging ≥300% (ASTM D5250) | Before aging/after aging ≥300% |
| Tensile Strength (Physical) | Before aging/after aging ≥14MPa (ASTM D5250) | Before aging/after aging ≥14MPa |
| Freedom from Pinholes | Meets 21 CFR 800.20, ASTM D5250, ASTM D5151 (Inspection Level I, AQL 2.5) | Meets ASTM D5151 (Holes: Inspection Level I, AQL 2.5) |
| Residual Powder | Meets ASTM D6124-06 (Reapproved 2011) | Meets ASTM D6124 (Results generated values below 2mg of residual powder) |
| Biocompatibility (Skin Irritation & Sensitization) | Meets ISO 10993-10:2002/Amd.1:2006 | Non-irritant or non-sensitizer (Meets ISO 10993-10:2002/Amd.1:2006) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" sample size in the context of clinical trials or AI validation. Instead, the performance data is generated from testing batches of gloves to ensure compliance with the AQL (Acceptance Quality Limit) for pinholes and other physical property tests as per the mentioned ASTM standards. These tests are internal to the manufacturing process and documented for regulatory submission. The data provenance is from the manufacturer's own testing in China, as the applicant is Cabin Plastic Co., Ltd. from China. The studies are not prospective or retrospective clinical studies but rather product testing and characterization.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
Not applicable. For this device, ground truth is established by objective measurements against quantitative performance standards (e.g., tensile strength, dimensions, pinhole AQL) as defined by ASTM and ISO standards, and regulatory requirements (e.g., 21 CFR 800.20). No human experts are used to "establish ground truth" in the clinical sense for this type of device.
4. Adjudication Method for the Test Set
Not applicable. Measurements against established technical standards do not typically involve adjudication panels in the way clinical studies or image-based AI studies do.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No MRMC study was done. This type of study is not relevant for a patient examination glove. The device's performance is assessed based on its physical and chemical properties, not diagnostic accuracy requiring human reader interpretation with or without AI.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done
Not applicable. There is no algorithm or AI component in this device. Performance is inherently "standalone" in the sense of the physical glove performing its intended function (barrier protection) based on its material properties and manufacturing quality.
7. The Type of Ground Truth Used
The ground truth used for demonstrating substantial equivalence is established by objective technical standards and regulatory requirements. This includes:
- ASTM Standard D5250-06 (Reaffirmation 2011): Specification for Vinyl Patient Examination Gloves.
- ASTM Standard D5151-06 (Reapproved 2011): Standard Test Method for Detection of Pinholes in Medical Gloves.
- ASTM Standard D6124-06 (Reapproved 2011): Standard Test Method for Residual Powder on Medical Gloves.
- 21 CFR 800.20: Regulations regarding medical device requirements.
- ISO 10993-10:2002/Amd.1:2006(E): Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (for biocompatibility).
8. The Sample Size for the Training Set
Not applicable. This device does not involve machine learning or AI, and therefore does not have a "training set" in the computational sense. The "training" in manufacturing refers to adherence to good manufacturing practices and quality control processes to consistently produce gloves meeting the established standards.
9. How the Ground Truth for the Training Set Was Established
Not applicable. See point 8. The manufacturing process is designed to meet the aforementioned ASTM, ISO, and CFR standards, which serve as the "ground truth" for quality and performance.
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Section C
510(k) Summary
"This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92."
"The assigned 510(k) number is: K130751 " (applicant leave blank)
Premarket Notification [510(k)] Summary
[(a)(1)]. The summary contains on the first page, preferably on your letterhead paper, the submitter's name, address, phone and fax numbers, name of contact person, and date the summary was prepared :
| Submitter's name : | Cabin Plastic Co., Ltd. |
|---|---|
| Submitter's address : | No.66, Hongqi St. Shijiazhuang, 050000, China |
| Phone number : | (86) 311-67699828 |
| Fax number : | (86) 311-67699906 |
| Name of contact person: | Mr. Wang Chaoguo |
| Date the summary was prepared: | 2014-03-04 |
[(a)(2)]. The name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known
| Device Name: | Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) |
|---|---|
| Proprietary/Trade name: | "Cabin Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)" |
| Common Name: | Patient examination glove |
| Classification Name: | Patient examination glove |
| Device Classification: | I |
| Regulation Number: | 21 CFR 880.6250 |
| Panel: | General Hospital (80) |
| Product Code: | LYZ |
((a)(3)]. An identification of the legally marketed device to which your firm is claiming substantial equivalence .
Class I* Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) that meets all of the requirements of ASTM standard D 5250-06 (Reaffirmation 2011).
Predicate device : Powder free Vinyl Patient Examination Gloves, Clear(Non-colored), Shijiazhuang Fuguan Plastic Products Co., Ltd. K032908 .
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](a)(4)] A description of the device
Device Description : Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) that meets all of the requirements of ASTM standard D 5250-06(Reaffirmation 2011).
-- How the device functions:
PVC films form a barrier to body fluids and bloodborne Pathogens
-- Scientific concepts that form the basis for the device
The PVC rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure.
-- Physical and performance characteristics such as design, materials and physical properties: PVC gloves are known to create a barrier to bloodborne pathogens and body fluids. ASTM conforming tensile properties create a glove that is strong and flexible. The glove is manufactured in accordance with the requirements of ASTM D5250 and ASTM D5151 requirements.
[(a)(5)] The summary describes the intended use of the device
Device Intended Use: Powder Free Vinyl 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)(6)] A summary of the technological characteristics of new device compared to the predicate device.
| Features &Description | Predicate Device | Subject Device | Result ofComparison |
|---|---|---|---|
| Company | Shijiazhuang Fuguan PlasticProducts Co., Ltd. | Cabin Plastic Co., Ltd. | -- |
| 510(K) Number | K032908 | K130751 | Same |
| Product name | Powder Free Vinyl PatientExamination Gloves, Clear(Non-colored) | Powder Free Vinyl PatientExamination Gloves, Clear(non-colored) | Same |
| Product Code | LYZ | LYZ | Same |
| Size | Small/ Medium/Large/X large | Small/ Medium/Large/X large | Substantiallyequivalent |
| Intend for use | Powder free Vinyl PatientExamination Gloves,Clear(Non-colored)is adisposable device intended formedical purposes that is worn onthe examiner's hand or finger toprevent contamination betweenpatient and examiner. | Powder free Vinyl PatientExamination Gloves, Clear(Non-colored) is a disposabledevice intended for medicalpurposes that is worn on theexaminer's hand or finger toprevent contamination betweenpatient and examiner. | Substantiallyequivalent |
| DeviceDescription andSpecifications | Meets ASTM D5250-06 (Reapproved 2011) | Meets ASTM D5250 -06(Reapproved 2011) | Substantiallyequivalent |
| Dimensions-- Length | Meets ASTM D5250-06 (Reapproved 2011) | 230mm min for all sizes | Substantiallyequivalent |
| ≥230mm min. | |||
| Dimensions-- Width | Meets ASTM D5250-06 (Reapproved 2011)Small 80-90 mmrMedium 90-100mmLarge 100-110mmX large 110-120 mm | Small 80-85 mmMedium 95-97 mmLarge 102-108mmX large 114-118 mm | Substantiallyequivalent |
| Dimensions-- Thickness | Meets ASTM D5250-06 (Reapproved 2011) | ||
| Finger 0.05mm min.Palm 0.08mm min. | Finger 0.05mm min.Palm 0.08mm min. | ||
| Physical Properties | Meets ASTM D5250-06 (Reapproved 2011)Before aging/after agingElongation ≥300%Tensile Strength≥14MPa | Before aging/after agingElongation ≥300%Tensile Strength≥ 14MPa | Substantiallyequivalent |
| Freedom fromPinholes | Meets• 21 CFR 800.20• ASTM D5250-06(Reapproved 2011)• ASTM D 5151-06(Reapproved 2011) | Meets ASTM D5151-06(Reapproved 2011)HolesInspection Level IAQL2.5 | Substantiallyequivalent |
| Residual Powder | Meets ASTM D 6124-06(Reapproved 2011) | Meets ASTM D 6124-06(Reapproved 2011)Results generated values below2mg of residual powder | Substantiallyequivalent |
| Compare allmaterials used tofabricate thedevices | PVC | PVC | Substantiallyequivalent |
| Dusting orDonning Powder: | PU | PU | Substantiallyequivalent |
| Dusting orDonning Powder:name | PU | Surface Coating Agent | Substantiallyequivalent |
| Compareperformance datasupportingsubstantialequivalence | MeetsASTM D5151-06(Reapproved 2011)ASTM D5250-06(Reapproved 2011)ASTM D6124-06(Reapproved 2011) | MeetsASTM D5151-06(Reapproved 2011)ASTM D5250-06(Reapproved 2011)ASTM D6124-06(Reapproved 2011) | Substantiallyequivalent |
| Single Patient Use | Single Patient Use | Single Patient Use | Substantiallyequivalent |
| Biocompatibility | SKIN IRRITATION DERMALand SENSITIZATIONSTUDIES Meets ISO10993-10 :2002/Amd.1:2006 | The test article was a non- irritantor non- sensitizer.SKIN IRRITATION DERMAL andSENSITIZATION STUDIESMeets ISO10993-10 :2002/Amd.1:2006 | Substantiallyequivalent |
| Labeling for thelegally marketeddevice to whichsubstantialequivalence isclaimed. | -Powder Free-devices color:Clear(Non-colored)-Patient Examination Glove-Non sterile-Single Use Only- Manufactured For:- Lot | -Powder Free-devices color: Clear(Non-colored)-Patient Examination Glove-Non sterile-Single Use Only- Manufactured For:- Lot | Substantiallyequivalent |
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.
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[(b)(1)] 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(Reaffirmation 2011), per ASTM D6124-06(Reaffirmation 2011), per 21 CFR 800.20 and ISO 10993-10: 2002/Amd. 1:2006(E).
[(b)(2)] 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.
Section C(rev.03)
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[(b)(3)] The conclusions drawn from the nonclinical and clinical tests that demonstrate that the device is as safe,as effective, and performed as well or better than the legally marketed device identified in (a)(3).
It can be concluded that the Powder Free Vinyl Patient Examination Gloves meet the ASTM standard or equivalent standard and FDA requirements for waterleak test on pinhole AQL., meet labeling claims and 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 Vinyl Patient Examination Gloves, Clear(Non-colored), Shijiazhuang Fuguan Plastic Products Co., Ltd. K032908 .
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 5, 2014
Cabin Plastic Company, Limited c/o Mr. Chu Xiaoan Official Correspondent Room 1606 Bldg. 1 Jianxiang Yuan No. 209 Bei Si Huan Zhong, Haidan District Beijing, 100083, CHINA
Re: K130751
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: I Product Code: LYZ Dated: January 2, 2014 Received: January 8, 2014
Dear Mr. Xiaoan:
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 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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Page 2 - Mr. Xiaoan
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 (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/ResourcesforYou/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.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm 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/ResourcesforYou/Industry/default.htm.
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Erin I. Keith, M.S. Acting 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
510(k) Number (if known) K 130751
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 purposes 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)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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FORM FDA 3881 (9/13)
PSC Publishing Services (301) 413-6739 1:2
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
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§ 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.