(92 days)
80 LYY
Not Found
No
The device description and intended use clearly define a simple, disposable glove with no mention of any computational or analytical capabilities, let alone AI/ML. The performance studies focus on physical properties and standards, not algorithmic performance.
No
The device, a patient examination glove, is intended to prevent contamination between the patient and examiner, not to treat or cure a disease or medical condition in the patient.
No
A patient examination glove is used for contamination prevention during examination, not for diagnosing conditions.
No
The device description clearly states it is a "powder-free patient examination glove," which is a physical, hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is clearly stated as a "disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner." This describes a physical barrier device used during patient examination, not a device used to examine specimens in vitro (outside the body) to diagnose or monitor a condition.
- Device Description: The description reiterates the same function as the intended use.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), using reagents, or providing diagnostic information based on laboratory testing.
- Predicate Device: The predicate device is listed as "Class I Examination Gloves," which are also not IVDs.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device is a physical barrier for protection during examination.
N/A
Intended Use / Indications for Use
A powder-free 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.
Product codes (comma separated list FDA assigned to the subject device)
80 LYY, LYY
Device Description
A powder-free 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand or finger
Indicated Patient Age Range
Not Found
Intended User / Care Setting
examiner
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance data is the same as mentioned immediately above.
Clinical date is not needed for gloves or for most devices cleared by the 510 (K) process.
Non-clinical data We certify that our gloves meet or exceed the ASTM D 3578-05ae2 Standard. Meets FDA pin hole requirement. Meets labeling claim.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Class I Examination Gloves 80 LYY marketed meeting ASTM D 3578-05ae2
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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JUFACTURE OF LATEX GLOVES
Jln. Utama No. 98 PUJI MULYO SUNGGAL - DELI SERDANG SUMATERA UTARA - INDONESIA
AUG 2 8 2008
Telp. 62-61 - 8459160 62-61 - 8459170 Fax. 62-61 - 8459180
Page Numbers 1 of 2
"510 (K)" SUMMARY
| (1) Name of applicant | |
|---|---|
| Address |
: SIVA PRAKASH, General Manager : PT. Maja Agung Latexindo J1. Utama No. 08, Puji Mulio, Sunggal 20352 North Sumatera - Indonesia Phone No. : 62-61-8459170 Fax No. : 62-61-8459180
Contact person in U.S.A
: Emmy Tjoeng : 909-591-8855 Phone No. : 909-628-6283 Fax No. : emmyt@smcgloves.com Email
| (2) Device details | |
|---|---|
| Trade Name | : Powderfree Latex Examination Gloves |
| Classification Name | : Powderfree Latex Examination Gloves |
: 80 LYY (3) Product Code
- (4) Equivalent device legally : Class I Examination Gloves 80 LYY marketed meeting ASTM D 3578-05ae2
: A powder-free patient examination glove is a disposable device (5) Intended use intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
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Image /page/1/Picture/0 description: The image shows a logo with the letters 'Ma' in a stylized font. The letters are black and appear to be handwritten or calligraphic. The background behind the letters consists of horizontal lines, creating a striped effect. The logo is partially obscured by a black shape on the left side.
Jin. Utama No. 98 PUJI MULYO SUNGGAL - DELI SERDANG Sumatera Utara - Indonesia
Telp. 62-61 - 8459160 62-61 - 8459170 Fax. 62-61 - 8459180
Page Numbers 2 of 2
(6) Technological characteristic of the gloves.
| a. Dimensions
| Sizes | Small | Medium | Large | X-Large | |
|---|---|---|---|---|---|
| Length mm (min.) | 240 | 240 | 240 | 240 | ± 5 |
| PalmWidth mm | 80 | 95 | 105 | 110 | ± 10 |
| Thickness (min) | |||||
| 1. Cuff mm | 0.08 | 0.08 | 0.08 | 0.08 | |
| 2. Palm mm | 0.10 | 0.10 | 0.10 | 0.10 | |
| 3. Finger Tip mm | 0.10 | 0.10 | 0.10 | 0.10 | |
| b. Physical Properties | |||||
| Before ageing | After ageing | ||||
| at 70°C 168 hrs. | |||||
| Tensile Strength | : 18 Mpa (min) | 14 Mpa (min) | |||
| Ultimate Elongation | : 650 % (min.) | 500 % (min.) |
(7) Performance data is the same as mentioned immediately above.
- (8) Clinical date is not needed for gloves or for most devices cleared by the 510 (K) process.
- (9) Non-clinical data We certify that our gloves meet or exceed the ASTM D 3578-05ae2 Standard. Meets FDA pin hole requirement. Meets labeling claim.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is depicted in black, and the text is also in black. The logo is simple and recognizable, and it is often used on official documents and websites related to the Department of Health & Human Services.
Public Health Service
AUG 2 8 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
PT. Maja Agung Latexindo C/O Ms. Emmy Tjoeng Marketing Director Shamrock Manufacturing Company Incorporated 5445 Daniels Street Chino, California 91710
Re: K081488
Trade/Device Name: Powder Free Latex Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: August 15, 2008 Received: August 22, 2008
Dear Ms. Tjoeng:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
3
Page 2 - Ms. Tjoeng
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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Chien-Lung, Ph.D.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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PT. MAJA AGUNG LATEXINDO
MANUFACTURING OF LATEX GLOVES
Jln. Utama No. 98 PUJI MULIO SUNGGAL - DELI SERDANG SUMATERA UTARA - INDONESIA Telp. 62-61 - 8459160 62-61 - 8459170 Fax. 62-61 - 8459180
- . «
ANNEXURE II
INDICATION FOR USE
| Applicant | : PT. Maja Agung Latexindo |
|---|---|
| 510(k) Number (if known) | : |
| Device Name | : Powder Free Latex Examination Gloves |
| Indication for use | : |
A powder-free 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.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR Over-The-Counter Use X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Anesthesiology, General Hospital | |
| Infection Control, Dental Devices | |
| 510(k) Number: | K081488 |