(172 days)
A medical gloves is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient's body, fluids, waste, or environment.
A patient examination glove is a disposable device intended for medical purpose worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Glove, Disposable, Non-sterile, Patient Examination, Vinyl (Powder Free)
The provided text describes the acceptance criteria and performance of the EVERGREEN MEDICAL PRODUCTS Vinyl Patient Examination Gloves - Powder Free. However, it does not contain information about a study proving the device meets the acceptance criteria in the manner of a multi-reader, multi-case (MRMC) comparative effectiveness study, or a standalone (algorithm only) performance study as typically seen for AI/ML medical devices. The document is a 510(k) summary for a medical device (examination gloves), which follows a different set of regulatory requirements focused on demonstrating substantial equivalence to a predicate device.
Instead, the "study" described in this document is essentially a series of quality characteristic tests performed against established ASTM and FDA standards for patient examination gloves.
Here's the breakdown of the information requested, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Specification) | Reported Device Performance (Implied from meeting specifications) |
|---|---|---|
| Physical Dimensions | ||
| Circumference of Palm (mm) | Small: 178; Medium: 210; Large: 218; Ex-Large: 230 | Met (implied by statement "meet ASTM D5250-99 performance standard") |
| Total Length (+/- 5 mm) | Small: 240; Medium: 245; Large: 245; Ex-Large: 245 | Met (implied by statement "meet ASTM D5250-99 performance standard") |
| Length of Fingers (mm) | Thumb: 55-63; Index: 66-78; Middle: 74-92; Ring: 69-82; Little: 54-62 | Met (implied by statement "meet ASTM D5250-99 performance standard") |
| Circumference of Fingers (mm) | Thumb: 63-83; Index: 56-74; Middle: 59-76; Ring: 56-73; Little: 50-66 | Met (implied by statement "meet ASTM D5250-99 performance standard") |
| Mechanical Properties | ||
| Tensile Strength (Mpa) | Min. 10.0 | Met Min. 10.0 (implied by statement "meet ASTM D5250-99 performance standard") |
| Elongation | 350% | Met 350% (implied by statement "meet ASTM D5250-99 performance standard") |
| Weight | 7.0 (Small), 8.0 (Medium), 9.0 (Large), 9.5 (Ex-Large) +/- 0.2g | Met (implied by statement "meet ASTM D5250-99 performance standard") |
| Thickness | Finger Tip: 0.08 mm +/- 0.02 mm; Cuff: 0.09 mm +/- 0.02 mm; Palm: 0.15 mm +/- 0.02 mm | Met (implied by statement "meet ASTM D5250-99 performance standard") |
| Quality Assurance | Under 2.5% Pinhole Rate (FDA Glove 1000ml Water Leak Test) | Met (stated under Quality Assurance table entry) and explicitly stated in the conclusion: "meet pinhole requirements" |
| Biocompatibility | Primary Dermal Irritation in Rabbits (Pass); Guinea Pig Sensitization (Buehler) (Pass) | Met (implied by testing issued by Consumer Products Testing Co.) |
| Powder Residue | Powder Free, Weight of all types of residual powder on medium size glove is 0 milligram per glove (implicit standard for "Powder Free" claims) | 0 milligram per glove (explicitly stated: "Weight of all types of residual powder on medium size glove is 0 milligram per glove. The gloves are powder free and the process does not include any powder.") |
| Overall Performance Standard | ASTM Specification D 5250-99 | Met (explicitly stated in the conclusion: "The vinyl Patient Examination gloves (powder free)... meet ASTM D5250-99 performance standard") |
2. Sample size used for the test set and the data provenance:
- The document does not specify a distinct "test set" sample size in terms of number of gloves tested for each characteristic. It refers to established standards and tests (e.g., JIS-S-2045.509, JIS-S-2045.5.2, FDA Glove 1000ml Water Leak Test, Primary Dermal Irritation in Rabbits, Guinea Pig Sensitization). These standards imply specific sampling plans.
- Data Provenance: The tests for biocompatibility were "Issued by Consumer Products Testing Co." The document states the manufacturer is located in Shijiazhuang City, Hebei, China. Thus, the provenance of the testing data is likely China. The study is retrospective in the sense that the data presented reflects the results of quality control and testing performed on manufactured batches to demonstrate compliance with standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This concept is not applicable here as this is a physical medical device (gloves) and not an AI/ML diagnostic or image analysis device that requires expert consensus for "ground truth." The "ground truth" for the performance characteristics are the established ASTM and FDA standards themselves. The assessment is against these objective measurements.
4. Adjudication method for the test set:
- This concept is not applicable. Performance against physical and chemical specifications does not involve "adjudication" by experts in the context of diagnostic interpretation. The methods are standardized physical and chemical tests (e.g., measuring length, tensile strength, pinhole rate via water leak test, biological irritation tests).
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:
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI/ML diagnostic systems, not for examination gloves.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No, a standalone (algorithm only) performance study was not done. This type of study is relevant for AI/ML diagnostic systems, not for examination gloves.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance is adherence to established, objective material and physical specifications and testing standards (e.g., ASTM Specification D 5250-99 for physical properties, FDA Glove 1000ml Water Leak Test for pinholes, and standard biocompatibility tests).
8. The sample size for the training set:
- This concept is not applicable. This device is not an AI/ML algorithm that requires a "training set." The manufacturing process itself (described in Section 10.0) is continuously refined and controlled, but there isn't a "training set" in the sense of data used to train a model.
9. How the ground truth for the training set was established:
- This concept is not applicable, as there is no "training set." The standards for glove manufacturing and performance are established by regulatory bodies and industrial organizations (e.g., ASTM, FDA) based on extensive research and consensus within the medical and materials science communities to ensure safety and effectiveness for their intended use.
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EVERGREEN MEDICAL PRODUCTS
No. 1, Evergreen Rd., The North of Beishimen Village, Xiaozuo Town, Jingxing County, Shijiazhuang City, Hebei 050306, China Fax: + (86 311) 236 0670 Tel: + (86 311) 236 1018, 236 1035
R 994613
510 (K) SUMMARY
Date: May 03, 2000 Total pages: 4
1.0 APPLICANT:
Evergreen Medical Products (Jingxing) Co., Ltd. No. 1, Evergreen Rd., The North of Beishimen Village, Xiaozuo Town, Jingxing County, Shijiazhuang City, Hebei 050306 China Tel: +(86 311) 236 1035, 236 0652 Fax: +(86 311) 236 0670 E-mail: cheniul@ms13.hinet.net
2.0 Contact Person:
Doreen Feng Tel: +(86 311) 236 1035, 236 0652 Fax: +(86 311) 236 0670
3.0 DEVICE CLASS: II
PRODUCT CODE: Vinyl (Powder Free) - 80 LYZ
- 4.0SPECIFICATION: Glove, Patient Examination, Vinyl (Powder Free) Meet all the current specifications listed under ASTM Specification D 5250-99
5.0 DEVICE DESCRIPTION:
Glove, Disposable, Non-sterile, Patient Examination, Vinyl (Powder Free)
6.0 INDICATION FOR USE (INTENDED USE):
A medical gloves is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient's body, fluids, waste, or environment.
7.0INNER SURFACE: Powder Free
8.0 BIOCOMPATIBILITY TESTING:
- -Primary Dermal Irritation in Rabbits
- Guinea Pig Sensitization (Buehler) -
Issued by Consumer Products Testing Co.
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No. 1, Evergreen Rd., The North of Beishimen Village, Xiaozuo Town, Jingxing County, Shijiazhuang City, Hebei 050306, China Fax: + (86 311) 236 0670 Tel: + (86 311) 236 1018, 236 1035
9.0 QUALITY CHARACTERISTICS
510 (K) Summary: Page 2
SPECIFICATION OF VINYL GLOVES (Ambidextrous)
| SizeSpec. | Small | Medium | Large | Ex-Large | Test code |
|---|---|---|---|---|---|
| Circumferenceof Palm (mm)(Inch) | 1786-3/4 | 2107-3/4 | 2188-1/2 | 2309 | JIS-S-2045.509 |
| Total Length(+/- 5 mm) | 240 | 245 | 245 | 245 | JIS-S-2045.5.9 |
| Length ofFingers (mm)ThumbsIndex FingerMiddle FingerRing FingerLittle Finger | 5566746954 | 5770817450 | 6175837960 | 6378928262 | JIS-S-2045.5.9 |
| CircumferenceFingers (mm)ThumbIndex FingerMiddle FingerRing FingerLittle Finger | 6356595650 | 7164666357 | 7870726962 | 8374767366 | JIS-S-2045.5.9 |
| Tensile Strength(Mpa) | Min.10.0 | Min.10.0 | Min.10.0 | Min.10.0 | JIS-S-2045.5.2 |
| Elongation (Min.) | 350% | 350% | 350% | 350% | JIS-S-2045.5.2 |
| Weight (g/pc) | 7.0 | 8.0 | 9.0 | 9.5 | +/- 0.2g |
| Thickness | Finger Tip0.08 mm +/- 0.02 mmCuff0.09 mm +/- 0.02 mmPalm0.15 mm +/- 0.02 mm | ||||
| QualityAssurance | Under 2.5% Pinhole Rate | FDA Glove 1000mlWater Leak Test |
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Image /page/2/Picture/0 description: The image shows the logo for Evergreen Medical Products Co., LTD. The logo is written in both Chinese and English. The Chinese characters are on top, and the English words are on the bottom. The English words are written in a bold, sans-serif font.
No. 1, Evergreen Rd., The North of Beishimen Village, Xiaozuo Town, Jingxing County, Shijiazhuang City, Hebei 050306, China Tel: +(86 311) 236 1018, 236 1035 Fax: +(86 311) 236 0670
510 (K) Summary: Page 3
10.0 MANUFACTURING PROCESS OF POWDER FREE VINYL GLOVES:
Image /page/2/Figure/4 description: This image shows a flowchart of the manufacturing process of powder-free vinyl gloves. The process starts with the material being inspected, then formulated into a PVC film, followed by air-free treatment. The gloves are then dipped in PVC paste resin, heated to 240 degrees Celsius, and dipped a second time in a P.U. tank before drying and heating again to 240 degrees Celsius.
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Image /page/3/Picture/0 description: The image shows the logo for Evergreen Medical Products Co., LTD. The logo includes the company name in both Chinese and English. Below the company name is the address: No. 1 Evergreen Rd, The North of Boishimon Village, Yiaozue Town.
No. 1, Evergreen Rd., The North of Beishimen Village, Xiaozuo Town, Jingxing County, Shijiazhuang City, Hebei 050306, China Tel: +(86 311) 236 1018, 236 1035 Fax: +(86 311) 236 0670
510 (K) Summary: Page 4
Note:
A second time dipping process is adopted to compensate for the lack of donning powder, (Second time dipping process: After the glove is formed on the mold, the second stage of process is exercised by dipping the glove into a Poly Urethane Resin Emersion. Poly Urethane resin emersion is in the category of polymer which contains silicon. The characteristic of Poly Urethane enable to coat a membrane on the gloves which makes the surface of the gloves more lubricant and hence more easy to be worn and to be took off.
Weight of all types of residual powder on medium size glove is 0 milligram per glove. The gloves are powder free and the process does not include any powder.
11.0 CONCLUSION:
The vinyl Patient Examination gloves (powder free) manufactured by Evergreen Medical products (Jingxing) Co., Ltd. meet ASTM D5250-99 performance standard and meet pinhole requirements and labeling claims.
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Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized representation of three wavy lines, which are meant to symbolize the human form.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 3 2000
Ms. Doreen Fenq Evergreen Medial Products (Jingxing) Co. Ltd. #1, Evergreen Road, The North of Beishimen Village, Xiazuo Town, Jingxing County, Shijiazhuang City, Hebei 050306 CHINA
Re : K994098 Trade Name: Vinyl Patient Examination Gloves Powder-Free Regulatory Class: I Product Code: LYZ Dated: January 21, 2000 Received: May 8, 2000
Dear Ms. Feng:
We have reviewed your Section 510 (k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in Please note: this response to your the Federal Register. premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Ms. Feng
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA deborized substantial equivalence of your device to a legally rinding or babbansaasic results in a classification for your marketed predication wour device to proceed to the market.
If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in regulagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on compriatee as (some with of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to the regulation encreted, "Arbidian" (2) CFR 807.97). Other general information on your responsibilities under the Act may be Intoined from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/6/Picture/0 description: The image shows the name of a company in both Chinese and English. The Chinese characters at the top read "長榮醫療用品有限公司". Below this, the English translation is written as "EVERGREEN MEDICAL PRODUCTS CO., LTD.". The text at the bottom reads "Villege Yiaочно Town".
No. 1, Evergreen Rd., The North of Beishimen Village, Xiaozuo Town, Jingxing County, Shijiazhuang City, Hebei 050306, China Fax: + (86 311) 236 0670 Tel: + (86 311) 236 1018, 236 1035
INDICATION FOR USE STATEMENT
| Applicant: | Evergreen Medical Products (Jingxing) Co., Ltd. |
|---|---|
| 510(K) Number: | K944098 |
| Device Name: | Vinyl Patient Examination Gloves - Powder Free |
Indication for use:
A patient examination glove is a disposable device intended for medical purpose worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Concurrence of CDRH Office of Device Evaluation (ODE)
Chiri AB IN
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number_x994049
Prescription Use Per 21 CFR 801.109
್ಗಾ OR Over-The-Counter _
§ 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.