BAM STANDARD. REINFORCED AND ULTRA REINFORCED SURGICAL GOWNS are sterile, single use, blue SMS Surgical Gowns intended to protect surgical patients and operating room personnel from the transfer of micro-organisms, body fluids and particulate material. The BAM STANDARD and REINFORCED SURGICAL GOWNS meet Level 3 of AAM Liguid Barrier Classifications and the BAM ULTRA REINFORCED GOWNS meet Level 4 of the AAMI Liquid Barrier Classifications in their critical zones. The base material of the gowns is the same for the three categories. The sizing is the same except the BAM ULTRA REINFORCED GOWNS are longer. The only other difference is the chest and sleeve reinforcement panels added. BAM Reinforced blue SMS Surgical Gowns have a one layer SMS fabric added to the chest and sleeves. BAM Ultra Reinforced Blue SMS Surgical Gowns have a PET + PE film reinforcement added to the chest and sleeves. These gowns have been EtO sterilized.

BAM STANDARD, REINFORCED AND ULTRA REINFORCED SURGICAL GOWNS are also sold as bulk non-sterile, single use items, to repackager/ relabeler establishments for further packaging and Ethylene Oxide (EtO) sterilization.

Device Description

BAM Standard, Reinforced and Ultra Reinforced Surgical Gowns are full-length, nonwoven SMS polypropylene gowns. They are constructed with hook and loop neck closures and tie waist closures. The BAM Standard Surgical Gown has an extra layer of SMS fabric reinforcement in the sleeves and BAM Reinforced Surgical Gown has an extra layer of fabric in critical areas. The Ultra Reinforced Gown has an extra layer of film Reinforced fabric in the critical areas for higher Barrier protection. BAM Standard and Reinforced Surgical Gowns meet the requirements for the Association for the Advancement of Medical Instrumentation (AAMI) Level 3 Requirements for liquid barrier performance. The BAM Ultra Reinforced Surgical Gown fully meets the requirements of AAMI Level 4 Liquid barrier requirements for Critical areas. The BAM Standard, Reinforced and Ultra-Reinforced and their predicates are provided sterile or nonsterile and for single use.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the BAM Surgical Gowns:

1. Table of Acceptance Criteria and Reported Device Performance

Device Type	Acceptance Criteria (AAMI Level)	Reported Device Performance (AAMI Level)
BAM Standard Surgical Gown	Level 3 (Liquid Barrier)	Level 3 (Liquid Barrier)
BAM Reinforced Surgical Gown	Level 3 (Liquid Barrier)	Level 3 (Liquid Barrier)
BAM Ultra-Reinforced Surgical Gown	Level 4 (Liquid Barrier, Critical Areas)	Level 4 (Liquid Barrier, Critical Areas)
All Gowns	Class 1, "normal flammability" (16 CFR Part 1610)	Meet Class 1, "normal flammability"
All Gowns	Biocompatibility (ISO 10993-10)	Meet Biocompatibility requirements

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the specific sample sizes used for each test (liquid barrier, flammability, biocompatibility). It only mentions that the gowns "have been tested in compliance with the requirements" of the respective standards.

Regarding data provenance, the document does not specify the country of origin of the data or whether the studies were retrospective or prospective. It implies the testing was conducted by or for BAM Corporation Ltd.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable to this type of device and study. The "ground truth" for surgical gowns like these is established by standardized, objective laboratory tests (e.g., AAMI liquid barrier tests, flammability tests) against defined performance criteria, not by expert consensus or interpretation of images or clinical data.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the evaluation relies on objective laboratory testing against established standards, not on expert adjudication of subjective assessments.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Reader Improvement

Not applicable. This is a medical device performance study, not an AI-assisted diagnostic or interpretative study involving human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a physical product (surgical gown), not a software algorithm.

7. The Type of Ground Truth Used

The ground truth used for evaluating the surgical gowns' performance is based on objective, standardized laboratory test results as defined by:

AAMI PB70:2003 "Liquid barrier performances and classification of protective apparel and drapes intended for use in healthcare facilities" for liquid barrier performance.
16 CFR Part 1610 for flammability.
ISO 10993-10 for biocompatibility.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this device.

Summary

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K093835
FEB - 4 2011

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510(k) Summary

Regulatory Affairs Contact	Ms. Mary MejaesBAM Corporation Ltd.Unit 1706 Tower 2, Grand Central PlazaNo. 138 Shatin Rural Committee Rd.Shatin, Hong Kong
Telephone:	852-2314-1300
Fax:	852-2314-1317
Email:	mary@bam-corp.com
Date Summary Prepared:	June 23, 2010
Common Name:	BAM Standard Surgical GownBAM Reinforced Surgical GownBAM Ultra-Reinforced Surgical Gown
Classification Name:	Surgical GownsClass 2, 21 CFR 878: 4040, Product FYA
Predicate Device:	Kimberly Clark Ultra Surgical GownKimberly Clark Ultra Film ReinforcedSurgical Gown
Device Description:	BAM Standard, Reinforced and Ultra ReinforcedSurgical Gowns are full-length, nonwoven SMSpolypropylene gowns. They are constructed withhook and loop neck closures and tie waistclosures. The BAM Standard Surgical Gown hasan extra layer of SMS fabric reinforcement in thesleeves and BAM Reinforced Surgical Gown hasan extra layer of fabric in critical areas. TheUltra Reinforced Gown has an extra layer of filmReinforced fabric in the critical areas for higherBarrier protection. BAM Standard andReinforced Surgical Gowns meet the requirementsfor the Association for the Advancement ofMedical Instrumentation (AAMI) Level 3

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Requirements for liquid barrier performance. The BAM Ultra Reinforced Surgical Gown fully meets the requirements of AAMI Level 4 Liquid barrier requirements for Critical areas. The BAM Standard, Reinforced and Ultra-Reinforced and their predicates are provided sterile or nonsterile and for single use. BAM Surgical Gowns are devices that are Intended Use intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids and particulate material. BAM Standard, Reinforced and Ultra Reinforced Substantial Equivalence Surgical Gowns are substantially equivalent to the predicate, Kimberly Clark Ultra Surgical Gown and Kimberly Clark Ultra Reinforced Surgical Gowns in intended use, design, materials and biocompatibility attributes. BAM Standard, Reinforced and Ultra Reinforced Surgical Gowns and their predicates are provided for single use and either Sterile or Non- sterile.

Product	Aspect	Comparison
BAM Standard, Reinforced and Ultra Reinforced Surgical Gowns	Basic Intended Use	Same as Kimberly Clark Ultra and Ultra Reinforced Surgical Gowns
BAM Standard, Reinforced and Ultra Reinforced Surgical Gowns	Material Used	SMS, Same as Kimberly Clark Ultra and Ultra Reinforced Surgical Gowns
BAM Standard, Reinforced and Ultra Reinforced Surgical Gowns	Sterility	Same as Kimberly Clark Ultra and Ultra Reinforced Surgical Gowns both sterile by EtO or non-sterile
BAM Standard, Reinforced, Ultra Reinforced Surgical Gowns	Testing	Same barrier testing and AAMI barrier classification levels as Kimberly Clark Ultra and Ultra Reinforced Surgical Gowns.

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Summary of Testing

BAM Standard and Reinforced Surgical Gowns have been tested in compliance with the requirements of AAMI Level 3 liquid barrier performance requirements of ANSI/AAMI PB70 :2003 " Liquid barrier performances and classification of protective apparel and drapes intended for use in healthcare facilities." The critical zones of BAM Ultra Reinforced Surgical Gowns have been tested in compliance with Level 4 liquid barrier performance requirements of ANSI/AAMI PB70:2003.

In addition BAM Standard, Reinforced and Ultra Reinforced Surgical Gowns have been tested and meet the requirements for Class 1, "normal flammability" in accordance with 16 CFR Part 1610. These devices also meet The requirements for biocompatibility per ISO 10993-10

Conclusion

The above statements are true representations of the Standard, Reinforced and Ultra Reinforced Surgical Gowns BAM Corporation Ltd. intends to market that believes the subject devices are substantially equivalent to the predicate devices. All data and information in the premarket notification are truthful and accurate and no material fact has been omitted.

49 Page

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Image /page/3/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name encircling the image of an eagle. The eagle is stylized with three lines representing the department's commitment to health, services, and human needs. The seal is a symbol of the HHS's mission to protect the health of all Americans and provide essential human services.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Ms. Mary Mejaes Director of Official Cerrespondent BAM Corporation Limited Unit 1706, Tower 2, Grand Central Plaza, No. 138 Shatin Rural Committee Road Shatin N.T. Hong Kong

FEB - 4 201

Re: K093835

Trade/Device Name: BAM Standard, Reinforced and Ultra Reinforced Surgical Gowns Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FYA Dated: January 3, 2011 Received: January 5, 2011

Dear Ms. Mejaes:

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-Ms. Mejacs

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 go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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.

Sincerely yours,

Anthony D. Watson, B.S., M.S., M.B.A. 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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Indications for Use

510(k) Number: K093835

Device Name: BAM STANDARD, REINFORCED AND ULTRA REINFORCED SURGICAL GOWNS

Indications For Use:

See Page 2 for a Product List

Prescription Use(Part 21 CFR 801 Subpart D)	AND/OR	Over-The-Counter Use(21 CFR 801 Subpart C)	X
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IFNEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign-OffOffice of Anesthesiology, General HospitalInfection Control, Dental Devices
510(k)
	Elite F. Clavins-Well (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:	K093835 Page 29

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No.	Model No.	Name	Size	Category
1	L: 1990XL:1991XXL: 1992	OR SMS Gown, Standard with FabricReinforcement Sleeves(BAM Sterile Standard blue SMS SurgicalGowns)	Large (L), X-Large (XL),XX-Large (XXL)	Standard
2.	L: 1990UXL:1991UXXL: 1992U	OR SMS Gown, Standard with FabricReinforcement Sleeves(BAM Non-sterile Standard blue SMSSurgical Gowns)	Large (L), X-Large (XL),XX-Large (XXL)	Standard
3.	L:2000XL:2001XXL:2002	OR SMS Gown, with Fabric ReinforcementChest and Sleeves(BAM Sterile Reinforced blue SMSSurgical Gowns)	Large (L), X-Large (XL),XX-Large (XXL)	SMS FabricReinforced
4.	L:2000UXL:2001UXXL:2002U	OR SMS Gown, with Fabric ReinforcementChest and Sleeves(BAM Non-sterile Reinforced blue SMSSurgical Gowns)	Large (L), X-Large (XL),XX-Large (XXL)	SMS FabricReinforced
5.	L: 2010XL:2011XXL: 2012	OR SMS Gown, with Film ReinforcementChest and Sleeves(BAM Sterile Ultra Reinforced blue SMSSurgical Gowns)	Large (L), X-Large (XL),XX-Large (XXL)	PET+ PE FilmReinforced
6.	L: 2010UXL:2011UXXL: 2012U	OR SMS Gown, with Film ReinforcementChest and Sleeves(BAM Non-sterile Ultra Reinforced blueSMS Surgical Gowns)	Large (L), X-Large (XL),XX-Large (XXL)	PET+PE FilmReinforced

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Regulation Number and Section

§ 878.4040 Surgical apparel.

(a)
Identification. Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.(b)
Classification. (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible.
(ii) Analysis and nonclinical testing must:
(A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and
(B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device.
(iii) NIOSH approved under its regulation.
(2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.