(608 days)
MOTEX Polyisoprene Powder-Free Sterile Surgical Gloves are powder-free surgeon's glove made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. The lubricating or dusting powder used in the glove is excluded.
Motex Powder-free Polyisoprene Surgical Sterile Gloves, Model # 6412 Nature, 6412_Blue; 6512_Nature, 6512_Blue are made of synthetic rubber. The sterile gloves are sterilized by the radiation method. 6412 Nature, 6412 Blue are of thin gloves. 6512 Nature, 6512 Blue are of thick gloves. They are processed by special treatment with no protein, and intended to be used in surgery to prevent the cross contamination between patients and users.
The provided text describes the acceptance criteria and the study results for the MOTEX Polyisoprene Powder-free Sterile Surgical Gloves. It is a 510(k) submission, demonstrating substantial equivalence to a predicate device, rather than a study proving the device meets acceptance criteria in the context of an AI/ML medical device. However, I can reframe the information to fit the requested table and provide a "study" description based on the non-clinical tests performed to show substantial equivalence.
Here's the breakdown of the information as requested, adapted for this type of medical device submission:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (Standard Reference) | Reported Device Performance |
|---|---|---|
| Dimensions | Meets ASTM D 3577-09 | Meets ASTM D 3577-09 |
| Length | Not specified in standard, but within product spec | $280 \pm 6$ mm |
| Width (various sizes) | Not specified in standard, but within product spec | size 6–77mm, 6.5–84mm, 7–91mm, 7.5–98mm, 8–102mm, 8.5–108mm |
| Thickness (finger, palm) | Not specified in standard, but within product spec | Model 6412: $0.13 \pm 0.03$ mm; Model 6512: $0.15 \pm 0.03$ mm |
| Physical Properties | Meets ASTM D 3577-09 | Meets ASTM D 3577-09 |
| Tensile Strength (Before Aging) | Not specified in standard, but within product spec | 24 Mpa |
| Tensile Strength (After Aging) | Not specified in standard, but within product spec | 23 Mpa |
| Ultimate Elongation (Before Aging) | Not specified in standard, but within product spec | 929% |
| Ultimate Elongation (After Aging) | Not specified in standard, but within product spec | 879% |
| Freedom from Holes | Meets ASTM D 3577-09 | Meets ASTM D 3577-09 |
| Water Leak Testing | Meets ASTM D 5151-06 (Reapproved 2011), AQL=1.5 | Meets ASTM D 5151-06 (Reapproved 2011), AQL=1.5 |
| Residual Powder Testing | Meets ASTM D 6124-06 (Reaffirmation 2011), < 2mg/glove | Meets ASTM D 6124-06 (Reaffirmation 2011), < 2mg/glove |
| Water Extractable Protein Testing | Meets ASTM D 5712-10, No protein content | Meets ASTM D 5712-10, No protein content |
| Biocompatibility | non-irritant & non-sensitizing (ISO10993-10:2010, ISO10993-12:2012) | non-irritant & non-sensitizing |
| Sterilization Validation | Pass ISO11137-1:2006 (Amendment 1:2013), ISO11137-2:2013, SAL: 1 x 10^-6 | Pass ISO11137-1:2006 (Amendment 1:2013), ISO11137-2:2013, SAL: 1 x 10^-6 |
Study Proving Device Meets Acceptance Criteria (Non-Clinical Testing for Substantial Equivalence)
The documented "study" is a collection of non-clinical tests performed to demonstrate that the MOTEX Polyisoprene Powder-free Sterile Surgical Gloves are "as safe, as effective, and perform as well as or better than" the predicate device (Esteem SMT Polyisoprene Powder-Free Surgical Sterile Gloves, K093300). This is a substantial equivalence claim under 510(k) regulations, not a typical clinical study with patient outcomes or a specific AI/ML performance evaluation.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: The document does not explicitly state the sample sizes for each specific test (e.g., how many gloves were tested for pinholes, how many for tensile strength). Compliance is reported against the ASTM and ISO standards, which themselves define minimum sample sizes for their respective tests. The provenance is from Shanghai Motex Healthcare Co., Ltd., China.
- Data Provenance: The tests were conducted by Shanghai Motex Healthcare Co., Ltd. in China, or by third-party labs on their behalf, to demonstrate compliance with international standards (ASTM and ISO). The data is retrospective in the sense that the tests were completed and evaluated prior to this 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is Not Applicable to this type of device and submission. "Ground truth" established by experts (like radiologists) is relevant for diagnostic devices, particularly AI/ML applications. For surgical gloves, the "ground truth" is adherence to established engineering and material science standards (ASTM, ISO), which are verified through empirical laboratory testing.
4. Adjudication method for the test set
This is Not Applicable. Adjudication methods (like 2+1 reads) are used for resolving disagreements in expert interpretations, typically in diagnostic imaging. The "adjudication" here is the pass/fail result against objective criteria defined by the relevant standards.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is Not Applicable. This is a medical device for surgical procedures (gloves), not an AI/ML diagnostic or assistive tool. No human reader performance, AI assistance, or MRMC studies were conducted or are relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is Not Applicable. The device is a physical product (surgical gloves) and does not involve an algorithm or AI.
7. The type of ground truth used
The "ground truth" (or more accurately, the conformance criteria) for this device's performance is based on established international consensus standards (ASTM D3577-09, D5151-06, D6124-06, D5712-10, ISO10993, ISO11137) and laboratory test results demonstrating compliance with these standards.
- Expert Consensus: The standards themselves are developed through expert consensus, but not in the context of evaluating individual cases.
- Pathology/Outcomes Data: Not used as "ground truth" for the technical performance characteristics listed. Clinical data was stated as "Not applicable" for this particular submission.
8. The sample size for the training set
This is Not Applicable. There is no "training set" as this device is not an AI/ML algorithm.
9. How the ground truth for the training set was established
This is Not Applicable. There is no "training set" or corresponding ground truth establishment process for this device.
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SHANGHAI MOTEX HEATHCARE CO., LTD.
No.369, Jiasong Zhong Road, Huaxin, Qingpu, Shanghai, 201708, China Telephone: 86-21-5979 9888 Fax: 86-21-23010718
II. 510(K) Summary of Safety and Effectiveness (Per 21 CFR 807.92)
JUN 0 4 2014
2.1. General Information Establishment
- Manufacturer: Shanghai Motex Healthcare Co., Ltd.
- 특 Address: No.369, Jiasong Zhong Road, Huaxin, Qingpu, Shanghai, 201708, China
- 그 Owner Number: 9041164 Registration Number: 9615978
- 를 Contact Person: Dr. Jen, Ke-Min E-mail: ceirs.jen@msa.hinet.net Tel: +886-3-5208829 : Fax: +886-3-5209783
- 그 May 23, 2014 . Date Prepared:
Proprietary Name:
Subject Device:
- MOTEX Polyisoprene Powder-free Sterile Surgical Gloves, Model 6412 Nature MOTEX Polyisoprene Powder-free Sterile Surgical Gloves, Model 6412 Blue MOTEX Polyisoprene Powder-free Sterile Surgical Gloves, Model 6512 Nature MOTEX Polyisoprene Powder-free Sterile Surgical Gloves, Model 6512 Blue
| • Common Name: | Surgeon's glove |
|---|---|
| ---------------- | ----------------- |
- . Classification Name: Surgeon's Gloves
- Product Code: KGO, Class I
- Regulation Number: 878.4460
- Predicate device:
- . Esteem SMT Polyisoprene Powder-Free Surgical Sterile Gloves (K093300)
2.2. Safety and Effectiveness Information
-
Predicate Device:
Claim of Substantial Equivalence (SE) is made to Esteem SMT Polyisoprene Powder-Free Surgical Sterile Gloves (K093300) -
Device Description:
Motex Powder-free Polyisoprene Surgical Sterile Gloves, Model # 6412 Nature, 6412_Blue; 6512_Nature, 6512_Blue are made of synthetic rubber. The sterile gloves are sterilized by the radiation method. 6412 Nature, 6412 Blue are of thin gloves. 6512 Nature, 6512 Blue are of thick gloves. They are processed by special treatment with no protein, and intended to be used in surgery to prevent the cross contamination between patients and users.
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No.369, Jiasong Zhong Road, Huaxin, Qingpu, Shanghai, 201708, China Telephone: +86-21-5979 9888 Fax: +86-21-23010718
Motex Polyisoprene Powder-free Surgical Gloves variant models
| Model | Size | Product Description | Size | |||||
|---|---|---|---|---|---|---|---|---|
| Hand shape | Surface | Beaded cuff | Sterile | Color | Length (min) | Thickness (min) | ||
| 6412 | 6, 6.5, 7, 7.5, 8, 8.5(Sterile) | Curved Finger | Textured | • | • | Nature Blue | $280\pm6$ mm | $0.13\pm0.03$ mm |
| 6512 | 6, 6.5, 7, 7.5, 8, 8.5(Sterile) | Curved Finger | Textured | • | • | Nature Blue | $280\pm6$ mm | $0.15\pm0.03$ mm |
● Indications for Use:
MOTEX Polyisoprene Powder-Free Sterile Surgical Gloves are powder-free surgeon's glove made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. The lubricating or dusting powder used in the glove is excluded.
. Device Characteristics:
a. Single use only.
b. Not made with natural rubber latex.
● Powder Residual:
Surgeon's gloves meet powder level requirements for Powder-free" designation per ASTM D6124-06 (Reaffirmation 2011), Standard test method for residual powder on medical gloves.
The results generated values will be below 2mg of residual powder per glove.
● Biocompatibility Test Reports:
There are complied with the biological evaluation and the results of these studies show that the MOTEX Polyisoprene Powder-free Sterile Surgical Glove safety for its intended use, including:
- � Systemic Intravenous Injection
- Systemic Intraperitoneal Injection
- Skin Sensitization Test (Maximization test), Sesame oil extract;
- . Sensitization Test (Maximization test), Sodium Chloride extract;
- Skin Irritation Test, Sesame oil extract;
- Skin Irritation Test, Sodium Chloride extract;
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No.369, Jiasong Zhong Road, Huaxin, Qingpu, Shanghai, 201708, China Telephone: +86-21-5979 9888 Fax: +86-21-23010718
- Clinical Data:
Not applicable.
Comparison between the subject devices and the predicate device ●
| Feature | Predicate device | Subject device |
|---|---|---|
| Proprietary name | Esteem SMT PolyisoprenePowder-Free Surgical SterileGloves | Motex Powder-free PolyisopreneSurgical Gloves |
| 510(k) number | K093300 | K123126 |
| Model | SMT | 6412 (nature, blue)6512 (nature, blue) |
| Indications For Use | Powder-Free Polyisoprene SurgicalGloves are sterile disposabledevices made of imported syntheticrubber intended to be worn byoperating room personnel toprotect a surgical wound fromcontamination in the environmentswithin hospitals and otherhealthcare facilities. | MOTEX Polyisoprene Powder-FreeSterile Surgical Gloves arepowder-free surgeon's glove made ofsynthetic rubber intended to be wornby operating room personnel toprotect a surgical wound fromcontamination. The lubricating ordusting powder used in the glove isexcluded. |
| Prescription/OTCDevice | Over-the-Counter Use | Over-the-Counter Use |
| Product code | KGO | KGO |
| Classification | Class I | Class I |
| Regulation number | 878.4460 | 878.4460 |
| Manufacturingmaterial | Synthetic Polyisoprene | Synthetic Polyisoprene |
| Specifications | ||
| Size | N/A | Size: 6, 6.5, 7, 7.5, 8, 8.5 |
| Length (mm) | N/A | $280\pm6$ |
| Width (mm) | N/A | size 6--77, size 6.5--84,size 7--91, size 7.5--98,size 8--102, size 8.5-108 |
| Thickness (finger,palm, cuff) (mm) | N/A | (6412)—$0.13\pm0.03$ ,$0.13\pm0.03$(6512)—$0.15\pm0.03$ ,$0.15\pm0.03$ |
| Tensile strength(before and afteraging), | N/A | Before aging: 24 MpaAfter aging: 23 Mpa |
| ultimate elongation(%) (before and afteraging) | N/A | Before aging : 929%After aging : 879% |
| Test for Pinhole,Dimensions, andPhysical properties | Meets ASTM D3577-09 | Meets ASTM D3577-09 |
| Residual powdertesting | Meets ASTM D 6124-06Residual powder < 2mg | Meets ASTM D6124-06(Reaffirmation 2011)Residual powder < 2mg |
| Water leaktesting(AQL) | Meets ASTM D 5151-06(AQL=1.5) | Meets ASTM D 5151-06(Reapproved 2011)(AQL=1.5) |
| Water extractableprotein testing | Meets ASTM D 5712-10No protein content | Meets ASTM D 5712-10No protein content |
| Biocompatibility | non irritantnon sensitizing | non irritantnon sensitizing |
| Sterilization Validation | Pass ISO11137-1ISO11137-2Sterilization Assurance Number:1 x 10-6 | Pass ISO11137-1:2006(Amendment 1:2013)ISO11137-2:2013Sterilization Assurance Number:1 x 10-6 |
Comparison Table
K 123 126
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SHANGHAI MOTEX HEALTHCARE CO., LTD.
No.369, Jiasong Zhong Road, Huaxin, Qingpu, Shanghai, 201708, China Telephone: +86-21-5979 9888 Fax: +86-21-23010718
● Discussion of the similarities
The same performance data of the Motex Powder-free Polyisoprene Sterile Surgical Gloves compared to the predicate device are summarized below.
| Characteristics | Standard |
|---|---|
| Dimensions | meets ASTM D 3577-09, |
| Physical Properties | meets ASTM D 3577-09, |
| Freedom from Holes | meets ASTM D 3577-09, |
| Residual powder testing | meets ASTM D 6124-06 (Reaffirmation 2011) |
| Water leak testing | meets ASTM D 5151-06 (Reapproved 2011) |
| Water extractable protein testing | meets ASTM D 5712-10 |
| Biocompatibility | non irritant & non- sensitizingISO10993-10:2010ISO10993-12:2012 |
| Sterilization Validation | Pass ISO11137-1:2006 (Amendment 1:2013)ISO11137-2:2013 |
K 123 126
4
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The subject device and the predicate device have the similar indications for use, the same material composition with Polyisoprene, the same technological characteristics, and the same biocompatibility and sterilization validation testing. There are no safety or effectiveness aspects raising.
● Discussion of the differences
The minor differences between them are thickness and size. Both of them meet ASTM D 3577-09, ASTM D 6124-06 (Reaffirmation 2011), ASTM D 5151-06 (Reapproved 2011), ASTM D 5712-10, and biocompatibility testing. The safety or effectiveness aspects are not raised.
● Conclusion
The conclusions drawn from the non-clinical tests demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device identified in the submission.
Dr. Jen, Ke-Min 510(k) correspondent person for Shanghai Motex Healthcare Co., Ltd.
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Image /page/5/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol is a representation of a human figure, with three overlapping profiles suggesting community and connection. The overall design is simple and conveys a sense of unity and service.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
JUL 18 2014
Shanghai Motex Healthcare Co., Ltd Dr. Jen, Ke-Min No. 369 Jiasong Zhong Road, Huaxin, Qingpu Shanghai 201708 CHINA
Re: K123126
Trade/Device Names: MOTEX Polyisoprene Powder-free Sterile Surgical Gloves, Model 6412 Nature: MOTEX Polyisoprene Powder-free Sterile Surgical Gloves, Model 6412 Blue; MOTEX Polyisoprene Powder-free Sterile Surgical Gloves, Model 6512 Nature: MOTEX Polyisoprene Powder-free Sterile Surgical Gloves, Model 6512 Blue
Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO Dated: April 26, 2014 Received: May 5, 2014
Dear Dr. Jen, Ke-Min:
This letter corrects our substantially equivalent letter of June 4, 2014.
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.
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Page 2 - Dr. Jen, Ke-Min
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 (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 Industry and Consumer Education 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. 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 Industry and Consumer Education 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.
Sincerely yours,
Mary S. Runner -S
Erin I. Keith, M.S. 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 | Form Approved: OMB No. 0910-0120 |
|---|---|
| Food and Drug Administration | Expiration Date: January 31, 2017 |
| Indications for Use | See PRA Statement below |
| 510(k) Number (if known) | K123126 |
|---|---|
| Device Name | MOTEX Polyisoprene Powder-free Sterile Surgical Gloves, Model 6412 Nature |
| MOTEX Polyisoprene Powder-free Sterile Surgical Gloves, Model 6412 Blue | |
| MOTEX Polyisoprene Powder-free Sterile Surgical Gloves, Model 6512 Nature | |
| MOTEX Polyisoprene Powder-free Sterile Surgical Gloves, Model 6512 Blue |
| Indications for Use (Describe) | MOTEX Polyisoprene Powder-Free Sterile Surgical Gloves are powder-free surgeon's glove made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. The lubricating or dusting powder used in the glove is excluded. |
|---|---|
| -------------------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| 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 | Elizabeth F. Claverie |
|---|---|
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:
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§ 878.4460 Non-powdered surgeon's glove.
(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's 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).